Introduction Human Immunodeficiency Virus, the retrovirus that causes Acquired Immune Deficiency Syndrome, is a major global public health threat. This chronic viral infection diminishes the immune system by attacking CD4 cells. The principal treatment is antiretroviral medication (ART), which significantly increases the life expectancy of HIV patients. However, ART does not address psychological issues, including depression, anxiety, and stress. Psychosocial factors are known to influence HIV disease progression through activation of stress-related biological pathways, including the hypothalamic-pituitary-adrenal (HPA) axis, inflammatory cytokine responses, and monoamine neurotransmitter dysregulation. Mind-body practices such as yoga may modulate these pathways by reducing physiological stress, improving emotional regulation, and enhancing overall well-being. The current trial aims to assess the effectiveness of yoga as an adjunct therapy on psychological parameters (depression, anxiety, and stress), quality of life, and medication adherence of people living with HIV on antiretroviral therapy at a tertiary care hospital in AIIMS, New Delhi, India.Materials and methods This study is a two-arm, parallel-group, open-label, blinded-endpoint, single-center, randomized controlled trial investigating the effects of a yoga therapy as an adjunct therapy in people living with HIV (PLHIV). Participants (n = 192) will be randomized to either 12 weeks of a Yoga therapy program (n = 96) or an Active control group, i.e., a prescribed brisk walk (n = 96). Both groups will receive standard treatment. The primary outcome is anxiety and depression scores (HADS-A and HADS-D), and the secondary outcomes are Stress (PSS), quality of life (WHOQOL-HIV BREF and SF-36 QoL), and medication adherence.Discussion The findings of this RCT will help shed light on yoga intervention to address the psychosocial dimensions of HIV. If shown to be effective, yoga as an adjunct intervention may promote a transition in HIV care from a predominantly biomedical framework to a holistic, patient-centered approach encompassing mental health and overall well-being. The study is approved by Institute Research Board Ethics (AIIMSA2969/03.01.2025, RP-46/25, OP-16/02.05.25, OP-18/05.12.2025) and is registered at Clinicaltrials.gov (CTRI/2025/03/081645). CTRI Link- https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIyNjUx&Enc=&userName=HIV,%20Yoga

Abstract Background People living with HIV (PLWH) face the dual challenge of human immunodeficiency virus(HIV) infection and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. It is associated with severe outcomes and a higher risk of mortality. In January 2021, the vaccination campaign against SARS-CoV-2 was launched in India and started mass administration of two types of vaccines. The two vaccines used on a large scale were, a recombinant, replication-deficient chimpanzee adenovirus vectored vaccine/ ChAdOx1 nCoV-19 (Covishield) and whole virion inactivated vaccine/ BBV152 (Covaxin).The study of cellular immune responses to COVID-19 vaccination in PLWH was vital for safeguarding this vulnerable population. Methods Study design: Prospective observational study Study population: The individuals recruited in the study were vaccinated with at least 2 doses and/or booster dose of the COVID-19 vaccine (COVISHIELD/COVAXIN). The individuals were segregated into two groups (PLWH and non-HIV-infected healthy individuals). Testing Method: Peripheral blood mononuclear cell (PBMC) were cultured to test the SARS-CoV-2-specific T cell immune response using activation induced marker/ intracellular cytokine staining (AIM/ICS) assay. Distribution of CD4 T lymphocytes count in HIV patients with mean CD4 count 470 cell/µl. Results We conducted did this study in two phases. The first phase was conducted between August 2022 and December 2022, while the second phase, or the follow-up, took place from January 2023 to December 2023. In the first phase/ first visit (V1), we recruited 50 adult PLWH and 40 adult healthy controls. Subsequently, in phase 2/follow-up/ second visit (V2), we achieved a follow-up rate of 100% in each arm. SARS-CoV2-specific cellular immune response after COVID-19 vaccination was comparable and durable IN PLWH as compared to healthy controls. Conclusion Comparable and durable immune response was observed in PLWH population on regular highly active antiretroviral therapy (HAART), with stable viral suppression and good CD4+ T cell counts. This was consistent over time across 1 year gap in both phases of the study and across different vaccine types. This outcome indicates that the cellular immune responses in our PLWH cohort is comparable and durable to that of the general population, which is a reassuring finding for the public health. SARS-CoV-2-specific CD8 T-cell immune response (scatter plots displaying the results of CD8 T cell assays, specifically evaluating the production of various cytokines (IFNγ (Interferon-gamma), TNFα (Tumor Necrosis Factor-alpha), and IL-2 (Interleukin 2), Granzyme B (Gran-B) at two different time points V1 and V2 (visit 1 and visit 2) with p values mentioned at the top. Disclosures All Authors: No reported disclosures

Introduction:Non-alcoholic fatty liver disease (NAFLD) and sarcopenia are increasingly identified in People Living with Human Immunodeficiency Virus (HIV) (PLHIV), contributing to cardiometabolic risk. This study aims to assess the prevalence and sarcometabolic associations of NAFLD in PLHIV. Methods:The study included 60 clinically stable patients on anti-retroviral treatment (>1 year). Patients with liver diseases, Hepatitis B/C, and significant alcohol intake were excluded. Hepatic inflammation was assessed via FibroScan-AST score (FAST), steatosis via Controlled Attenuation Parameter obtained from Fibroscan, and fibrosis using APRI, FIB-4, and Liver Stiffness Measurement. Sarcopenia was assessed using hand grip strength measured using a hydraulic dynamometer and skeletal muscle mass via Dual-Energy X-ray Absorptiometry. Sarcometabolic parameters were compared between PLHIV with and without NAFLD. Results:The study enrolled 60 patients (mean age: 37.12 ± 9.26 years; 46 (76.67%) males). The NAFLD frequency was 20%, with the majority having grade 3 steatosis. Hepatic inflammation (FAST score) was higher in NAFLD group (0.34 vs 0.12, P = 0.001). Obesity (body mass index) was significantly higher in NAFLD (66.67% vs 18.75%), P = 0.002}. The sarcopenia prevalence was 10%, with pre-sarcopenia (low muscle mass) of 45%. The muscle strength and mass were higher in NAFLD patients but not statistically significant. High triglycerides was a significant NAFLD risk factor {adjusted OR: 5.75 (1.11-29.73)}. Conclusion:NAFLD prevalence in stable Indian PLHIV is significant considering a high cardiovascular disease risk in this population. Hypertriglyceridemia seems to be significantly associated as a risk factor. Return to health and nutrition have positively impacted muscle health with a downside of developing fatty liver.

With the availability of free anti-retroviral therapy (ART) for children at government ART centres in India, it is the need of the hour to assess the outcome of children who have good adherence to ART. This study was aimed at assessing their survival and outcomes. This was an ambi-spective multicentric cohort study involving three sites in India–Delhi, Pune and Kolkata. Children (less than 18 years of age) who were already enrolled on ART were recruited and followed up for a total duration of 36 months. Their baseline demographic data were collected, and blood investigations were done at baseline and at 6-monthly follow-up. A composite outcome which implied either mortality or CD4 counts less than 350 cells/mm3 at the end of follow-up was used for analysis by logistic regression. A total of 343 children were enrolled. Among the 343 patients, 5 patients were lost to follow-up, 1 opted out, and 337 patients remained in follow-up till the end of the study period. Three deaths occurred during follow-up. CD4 counts less than 350/mm3 at baseline and at multiple follow-up visits were associated with the composite outcome (P < 0.05). Among the demographic variables, a history of blood transfusion as a risk factor for HIV acquisition was associated with the composite outcome (uOR − 9.66 [2.71–34.42], P < 0.001). No other variable was significantly and consistently associated with the outcome. Low CD4 counts at baseline and during follow-up are associated with poor outcomes in children living with HIV/AIDS.

Seroprevalence helps us to estimate the exact prevalence of a disease in a population. Although the world has been battling this pandemic for more than a year now, we still do not know about the burden of this disease in people living with HIV/AIDS (PLHA). Seroprevalence data in this population subset is scarce in most parts of the world, including India. The current study aimed to estimate the seroprevalence of anti-SARS-CoV-2 IgG antibody among PLHA.To determine the seroprevalence of SARS-CoV-2 antibodies in PLHA.This was a cross-sectional study conducted at a tertiary care hospital in North India. We recruited HIV positive patients following at the ART centre of the institute. Anti-SARS-CoV-2 IgG antibody levels targeting recombinant spike receptor-binding domain (RBD) protein of SARS CoV-2 were estimated in serum sample by the chemiluminescent immunoassay method.A total of 164 patients were recruited in the study with a mean age (±SD) of 41.2 (±15.4) years, of which 55% were male. Positive serology against SARS CoV-2 was detected in 14% patients (95% CI: 9.1-20.3%).The seroprevalence of COVID-19 infection in PLHA was lower than the general population in the same region, which ranged from 23.48% to 28.3% around the study period.

Perinatal transmission of Human Immunodeficiency Virus (HIV) infection is an important mode of transmission in developing countries. The aim of this study was to evaluate the epidemiology of perinatal transmission of HIV infection in pregnant women living with HIV/Acquired Immune Deficiency Syndrome (AIDS). A cross-sectional study was conducted in which HIV positive females who were pregnant at any time between April 2015 and July 2017 were interviewed and their case records analyzed. The collected data were entered and analyzed using Stata v11. Results were expressed as numbers and percentages for categorical variables and as mean and standard deviation (SD) for continuous variables. In all, 51 women were included in the study, 41 of whom had little knowledge concerning the transmission mode of HIV and its prevention. A total of 28 of these females were diagnosed with HIV during their pregnancy (First trimester -4, second trimester -18 and third trimester -6). A total of four babies delivered by these women were diagnosed with HIV. All the four babies were delivered by mothers who were diagnosed with HIV in or after the second trimester of the pregnancy. There is a need to create awareness amongst pregnant women about the importance of antenatal checkups.

The tuberculosis associated immune reconstitution inflammatory syndrome (TB-IRIS) frequently complicates the course of HIV/AIDS and HIV-TB treatment and its immunological mechanisms are poorly understood. Here, we investigated T-cells frequencies, their secreted chemokines and cytokines. In this prospective case-control study, HIV/AIDS and HIV-TB patients during treatment with highly active antiretroviral treatment (HAART) and anti-TB treatment were followed for TB-IRIS development. Age, gender. and BMI-matched patients without IRIS constituted as "Controls" (non-IRIS). Activation and proliferation were assessed in CD4 and CD8 cell compartments. CCR4, CCR6 and T-reg cells were also analysed'in PBMCs. Cytokines (IL-2, IL-4, 1L-10, IFN-gamma and TGF-beta 1) and chemokines (IP-10, MCP-1, MIG and RANTES) were measured in culture supernatants. Of 560 enrolled HIV/AIDS patients, TB-IRIS developed in 50 (8.9%) patients (25-paradoxical and 25-unmasking) at a median interval of 35-days (IQR, 24-78). After ART therapy, CD8+ T-cell proportion decreased in both paradoxical and unmasking-TB-IRIS as compared to non-IRIS. Simultaneously, activation of CD4+ T-cells was observed in unmasking TB-IRIS only. Similarly, CD161+ T-cells, Th17-cells and inflammatory cytokines like IFN-gamma, IP-10 and MIG elevated in both TB-IRIS subgroups as compared to non-IRIS.In conclusion, during HAART treatment the dominance of pro-inflammatory cells-and cytokines in TB-IRIS patients favours the development of IRIS event. On the other hand, in non-IRIS patients relative increase of anti-inflammatory cells and cytokines prevents the development of IRIS event.

Tuberculosis (TB) is an important cause of significant morbidity and mortality, particularly in patients living with human immunodeficiency virus (HIV ) infections. The co-infection of TB and HIV coinfection is further complicated by a relatively higher frequency of extra-pulmonary TB and upsurge of drug resistance. Musculoskeletal TB is a relatively less common form of extrapulmonary TB; involvement of carpometacarpal joint as an initial manifestation is even rarer. We herein present a retro positive patient who presented with low-grade fever, constitutional features and swelling of the base of the left thumb. On evaluation, he was found to have axillary and inguinal lymphadenopathy with lytic destruction of carpometacarpal joint as well as D10-D11 vertebrae. Fine needle aspiration (FNA) of synovial fluid was negative for tuberculosis but geneXpert from FNA of axillary node revealed Mycobacterium tuberculosis with rifampicin resistance. This case highlights the rarity of carpometacarpal joint involvement in TB as the initial manifestation and the importance of meticulous search of alternative sites for sampling in difficult situations such as osteoarticular TB. It also highlights the rising prevalence of drug-resistant TB and a definitive need for microbiological diagnosis wherever feasible.

With significant advancement in the tools and strategies available for diagnosis and management, there is an expected change in the epidemiological profile of patients living with HIV/AIDS (Human immunodeficiency syndrome/Acquired immunedeficiency syndrome). We retrospectively analyzed the changing epidemiological pattern of HIV infection over a period of 13 years in the anti-retroviral (ART) center of a tertiary care hospital in India. The study included a total of 9419 patients (8811 adults and 608 children) who were registered at our ART center between 2005 and 2017. Among adult patients, 68.9% patients were males and the mean age of presentation was 35.6±9.9 years. Heterosexual route was the most common route of transmission (95.5%). A total of 97.4% of pediatric patients acquired HIV infection via vertical transmission from their mothers. Most of the adult patients (77.1%) were educated only to primary level. Despite the economic growth in the country over the years, the monthly income of these patients has not significantly changed. The median CD4 count at the time of eligibility for starting ART was 244/μl of blood. An increasing trend in the baseline CD4 count was noticed from 2005 to 2017. Also, improved outcomes with less loss to follow up were noticed in the latter years. However, an increasing trend was also noted in the time gap between registration at the ART center and initiation of ART. Improvement in the baseline CD4 count and better treatment outcomes are indicators of a well-functioning national program. However, continued programmatic interventions are needed to further tackle the menace of HIV/AIDS in India.

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are the backbone of effective anti-retroviral therapy in the developing world. Efavirenz is the current NNRTI of choice due to reports of higher incidence of serious adverse events with nevirapine. Majority of patients with Human immunodeficiency virus (HIV) infection in India are still on nevirapine based therapy. The aim of the study was to evaluate the need of shifting these patients to efavirenz based therapy. A cross-sectional study was conducted on adult patients, who were on NNRTI based regimen for more than one year with good adherence. The patients were divided into efavirenz or nevirapine groups based on the treatments they were receiving at the time of study. The different arms were compared based on their clinical and laboratory profile, adverse events and immunological response. A total of 244 patients were recruited. A total of 125 patients were receiving nevirapine based regimen while 119 patients were receiving efavirenz based regimen. There was no significant difference in the frequency of hematological and biochemical derangements between the two groups. There was no difference in the median highest CD4 count achieved during therapy between the two groups. Clinically observed side effects were more common in the efavirenz group. These results suggest that there isn't enough evidence to shift patients tolerating long term nevirapine based therapy to efavirenz based therapy.

Nevirapine-based antiretroviral therapy against human immunodeficiency virus (HIV) among Tuberculosis (TB) co-infected individual is complicated as administration of rifampicin along with Nevirapine reduces the plasma concentration of Nevirapine. The objective of the present study is to compare efficacy and safety of Nevirapine 400 mg once daily (OD) based antiretroviral therapy (ART) with efavirenz based ART and twice daily dose (200 mg) of Nevirapine-based ART regimens in HIV-TB co-infected individuals. ART-naive HIV-TB patients were randomly assigned to receive either Nevirapine 400 mg OD with zidovudine and lamivudine (Group 1; n=30), Nevirapine 200 mg BD (Group 2; n=30), efavirenz 600 mg (Group 3, n=31); Nevirapine 400 mg OD with tenofovir (Group 4; n=30) and Nevirapine 400 mg OD without concomitant antitubercular therapy (ATT) (Group 5; n=30). The end points were virological (viral load), immunological (CD4 count) and clinical responses and progression of HIV disease marked by the failure of ART. Our results suggest that Nevirapine 400 mg OD based therapy is as effective as efavirenz-based ART in terms of clinical, immunological and virological response. Our data suggests that Nevirapine 400 mg OD group had favorable treatment outcome as compared to Nevirapine 200 mg 1 BD group. We conclude that Nevirapine 400 mg OD based ART combined with tenofovir and lamivudine could be an effective alternative to improve compliance in the resource-limited settings in patients with HIV-TB co-infection. Further large multicentric study with bigger sample size will be required to confirm these findings.

According to World Health Organization (WHO) guidelines, which have also been adopted by the National AIDS Control Organization (NACO), India, Efavirenz-based Anti-Retroviral Therapy (ART) is better in Human-Immunodeficiency-Virus (HIV)-infected patients who are also being treated with Rifampicin-based Anti-Tuberculous Therapy (ATT). However, Efavirenz is much more expensive. We hypothesize that Nevirapine is a cheaper alternative that possesses equal efficacy as Efavirenz in HIV-Tuberculosis (TB) co-infected patients.

BACKGROUND & OBJECTIVES:Limited data are available on malignancies in human immunodeficiency virus (HIV)-infected patients from India. We undertook this study to assess the frequency and spectrum of malignancies in HIV-infected adult patients during the first eight years of highly active antiretroviral therapy (HAART) rollout under the National ART Programme at a tertiary care centre in New Delhi, India.METHODS:Retrospective analysis of records of patients registered at the ART clinic between May 2005 and December 2013 was done.RESULTS:The study included 2598 HIV-infected adult patients with 8315 person-years of follow up. Malignancies were diagnosed in 26 patients with a rate of 3.1 (IQR 2.1-4.5) cases per 1000 person-years. The median age for those diagnosed with malignancy was 45 (IQR 36-54) yr, which was significantly (P<0.01) higher compared with those not developing malignancies 35 (IQR 30-40) yr. The median baseline CD4+ T-cell count in patients with malignancy was 135 (IQR 68-269) cells/µl compared to 164 (IQR 86-243) cells/µl in those without malignancies. AIDS-defining cancers (ADCs) were seen in 19 (73%) patients, while non-AIDS-defining cancers (NADCs) were observed in seven (27%) patients. Malignancies diagnosed included non-Hodgkin's lymphoma (16), carcinoma cervix (3), Hodgkin's lymphoma (2), carcinoma lung (2), hepatocellular carcinoma (1), and urinary bladder carcinoma (1). One patient had primary central nervous system lymphoma. There was no case of Kaposi's sarcoma.INTERPRETATION & CONCLUSIONS:Malignancies in HIV-infected adult patients were infrequent in patients attending the clinic. Majority of the patients presented with advanced immunosuppression and the ADCs, NHL in particular, were the commonest malignancies.

Background & objectives: There is a paucity of data from India on response to treatment of tuberculosis (TB) in patients with human immunodeficiency virus (HIV)-TB co-infection. This study was done to assess the frequency and pattern of TB, outcome of anti-tuberculosis treatment, and the factors related to poor outcome of TB treatment in adult patients with HIV infection. Methods: Retrospective review of case records of HIV-TB co-infected patients attending the antiretroviral therapy (ART) clinic in a tertiary care centre in north India was done. Results: Of the 1754 patients included in the study, 583 (33.2%) were diagnosed with active TB and 466 (79.9%) of them had CD4 count less than 200/΅l at diagnosis. Extrapulmonary TB was diagnosed in 372 (63.8%) patients [76 (20.4%) had disseminated TB], and pulmonary TB in 211 (36.2%) patients. "Favourable outcome" (cure and completed treatment) was observed in 332 (77%) patients. Unfavourable outcome included default (8.1%), treatment failure (1.6%), and death (13.2%). At 1-year post-treatment follow up, 12 (3.6%) patients had disease relapse. CD4 count of less than 200/ ΅l at diagnosis [OR-2.32, CI (1.06-5.09)], and retreatment cases [OR-2.91, CI (1.22-6.89)] were independent predictors of unfavourable outcome. Interpretation & conclusions: There is an urgent need to strengthen the information, education, communication activities and expand the ART services to meet the requirement of early testing and treatment initiation in patients co-infected with HIV-TB. The findings highlight the need for performing drug susceptibility testing (DST) for patients starting retreatment regimen to improve treatment outcome.

Background Despite the latest World Health Organization guidelines advocating daily therapy in HIV-TB co-infected individuals, there are few recent studies comparing outcomes of thrice-weekly anti-tuberculosis treatment in HIV-positive and HIV-negative patients with TB. The present study sets out to compare TB treatment outcomes in these two groups in the Indian national programme, which currently involves thrice-weekly therapy for all, regardless of HIV status. Methods HIV-positive and HIV-negative were consecutively screened for enrolment into this prospective observational study, carried out at the All India Institute of Medical Sciences hospital, New Delhi, India, between 2006 and 2010. Patients were given short-course thrice-weekly rifampicin-based therapy, with all HIV-positive patients being started on highly active antiretroviral therapy at least 14 days after commencing TB treatment. Patients were regularly followed-up for 24 months after completion of treatment. Results 150 HIV-positive, 155 HIV-negative patients were enrolled consecutively for the study. Significantly higher treatment success (93.5% vs. 76.7% at end of treatment, p < 0.001) and lower mortality (2.8% vs. 21.6% on follow up, p < 0.001) were observed in HIV-negative patients. No significant difference was found in treatment failure (p = 0.16), sputum smear (p = 0.58) and culture conversion (p = 0.55), and non-serious adverse event incidence (p = 0.851) between the two groups. Low baseline CD4 cell count (<100 cells/ mm 3 ) was the only predictor of mortality in HIV-TB patients (odds ratio 8 · 43, p = 0 · 013). Conclusions Thrice-weekly anti-tuberculosis therapy is more effective in HIV-negative than in HIV-positive patients. However, outcomes in this HIV co-infected cohort were found to be similar to those reported previously with daily therapy, with no safety concerns. This should prompt further study into whether intermittent or daily therapy should be used universally in resource-poor settings, using large well executed randomised controlled trials. Trial registration NCT%20No.%2000698334

Background & Objective . IRIS is an important complication that occurs during management of HIV-TB coinfection and it poses difficulty in diagnosis. Previous studies have reported variable incidence of IRIS. The present study was undertaken to describe the pattern of TB-associated IRIS using recently proposed consensus case-definitions for TB-IRIS for its use in resource-limited settings. Methods . A prospective analysis of ART-naïve adults started on HAART from November, 2008 to May, 2010 was done in a tertiary care hospital in north India. A total 224 patients divided into two groups, one with HIV-TB and the other with HIV alone, were followedup for a minimum period of 3 months. The diagnosis of TB was categorised as ‘‘definitive’’ and ‘‘probable’’. Results . Out of a total of 224 patients, 203 completed followup. Paradoxical TB-IRIS occurred in 5 of 123 (4%) HIV-TB patients while 6 of 80 (7.5%) HIV patients developed ART-associated TB. A reduction in plasma viral load was significantly (P=.016) associated with paradoxical TB-IRIS. No identifiable risk factors were associated with the development of ART-associated TB. Conclusion . The consensus case-definitions are useful tools in the diagnosis of TB-associated IRIS. High index of clinical suspicion is required for an early diagnosis.

Introduction The number of people infected with the human immunodeficiency virus (HIV) worldwide was estimated to be 33.2 million at the end of 2007. (1) The introduction of antiretroviral therapy (ART) has significantly reduced morbidity and mortality in HIV-infected patients in various developed and developing countries. (2-5) However, the outcome of ART in India's national ART programme has not been reported. Background India is a developing nation with approximately 2.4 million people living with HIV and a national prevalence of HIV infection in adults of 0.36%. (1) Until 2004, ART was available only to a select subset of patients through the private sector; most of the HIV-infected population was unable to afford ART. India's national ART programme was launched on 1 April 2004 under the National AIDS Control Organisation (NACO), as an initiative of the Ministry of Health and Family Welfare of the Government of India. The programme was launched in eight institutions in six states with a high prevalence Of HIV infection, and in the National Capital Region of Delhi. By December 2008, 197 ART centres were functioning in 31 states and union territories and more than 193 000 patients were accessing free ART through these centres. (6) Setting To ascertain the functioning and efficacy of the national ART programme, we assessed an ART centre that was opened at the All India Institute of Medical Sciences (AIIMS) Hospital, New Delhi, in May 2005. The AIIMS Hospital provides tertiary care to the population of Delhi and its neighbouring states, and most of its patients come from the lower socioeconomic strata. Patients with HIV infection tend to present in advanced stages of acquired immunodeficiency syndrome (AIDS) and are usually referred to the hospital's ART centre, which is staffed by a nodal officer, two physicians, a laboratory technician, a pharmacist, a nurse (who also acts as an AIDS educator), an ART counsellor, a data manager and a community health worker. The centre receives financial and logistic support from NACO through the Delhi State AIDS Control Society. This paper reports the outcomes of ART delivered from the clinic at the AIIMS Hospital and highlights some of the problems encountered in implementing ART. Methods To evaluate the effectiveness of the national ART programme at the AIIMS Hospital, we undertook a prospective observational study involving ART-naive patients who were started on ART between May 2005 and October 2006. ART was offered to these patients in accordance with NACO guidelines. (7) The regimen consisted of two nucleoside reverse transcriptase inhibitors and one non-nucleoside reverse transcriptase inhibitor. The available drugs included efavirenz, lamivudine, nevirapine and zidovudine. The medications were dispensed directly to the patients or their authorized representatives. Patients were seen 2 weeks after the start of ART and thereafter on a monthly basis. During each visit, patients were evaluated for drug toxicity, clinical improvement and opportunistic infections. Adherence was assessed during each visit by pill count, and, through counselling, patients were motivated to adhere to therapy. Patients who failed to turn up within a week of the scheduled visit were contacted by telephone. The CD4+ lymphocyte (CD4) count (cells/[micro]l) was estimated at baseline and at 6-month intervals during follow-up. Prophylaxis and treatment of opportunistic infections were in accordance with NACO guidelines. Anti-tuberculosis treatment was administered according to the Revised National Tuberculosis Control Programme guidelines. (8) Results Between 1 May 2005 and 31 October 2006, 1325 patients were enrolled in the ART clinic. Of these patients, 631 treatment-naive adolescents and adults were eligible for the study. Baseline characteristics for those enrolled in the study are provided in Table 1. …

PROBLEM:Antiretroviral therapy (ART) programmes have been successful in several countries. However, whether they would succeed as part of a national programme in a resource-constrained setting such as India is not clear. The outcomes and specific problems encountered in such a setting have not been adequately studied.APPROACH:We assessed the efficacy and functioning of India's national ART programme in a tertiary care centre in northern India. All ART-naive patients started on ART between May 2005 and October 2006 were included in the study and were followed until 31 April 2008. Periodic clinical and laboratory evaluations were carried out in accordance with national guidelines. Changes in CD4+ lymphocyte count, body weight and body mass index were assessed at follow-up, and the operational problems analysed.LOCAL SETTING:The setting was a tertiary care centre in northern India with a mixed population of patients, mostly of low socioeconomic status. The centre is reasonably well resourced but faces constraints in health-care delivery, such as lack of adequate human resources and a high patient load.RELEVANT CHANGES:The response to ART in the cohort studied was comparable to that reported from other countries. However, the programme had a high attrition rate, possibly due to patient-related factors and operational constraints.LESSONS LEARNT:A high rate of attrition can affect the overall efficacy and functioning of an ART programme. Addressing the issues causing attrition might improve patient outcomes in India and in other resource-constrained countries.

BACKGROUND & OBJECTIVES:A considerable proportion of patients with HIV associated tuberculosis (TB) started on highly active antiretroviral therapy (HAART) develop immune reconstitution inflammatory syndrome (IRIS), which is difficult to diagnose in a resource-limited setting. In view of the recently proposed consensus case-definitions for TB-IRIS for use in resource-limited settings we undertook this study to describe the incidence and risk factors of TB associated IRIS in a tertiary care hospital and research centre in north India.METHODS:Retrospective analysis of antiretroviral treatment (ART) naïve adults started on highly active ART (HAART) from June 2006 to September 2008 was done.RESULTS:Of the 627 patients studied, 237 (38%) had TB at the initiation of HAART. In total, 18 (7.5%) of 237 patients with TB at baseline had paradoxical TB-associated IRIS, and 12 (3%) of 390 patients without TB at baseline developed ART-associated TB. Most IRIS events occurred during the initial 30 days of HAART. Two patients developed TB-associated IRIS after 90 days of HAART. Using univariate analysis, low CD4+ cell count at baseline [64 (28-89) vs. 95 (52-150); P=0.009] and early initiation of HAART [33 (24-41) vs. 48 (35-61) days; P<0.001] were significantly associated with paradoxical TB-associated IRIS. No identifiable risk factors were associated with the development of ART-associated TB.INTERPRETATION & CONCLUSION:A considerable proportion of patients on HAART develop TB-associated IRIS. The consensus case-definition is a useful tool in resource-limited settings for the diagnosis of TB- associated IRIS.