INTRODUCTION:There was a growing need for practical guidelines for the most common OIs in Germany and Austria under consideration of the local epidemiological conditions.MATERIALS AND METHODS:The German and Austrian AIDS societies developed these guidelines between March 2010 and November 2011. A structured Medline research was performed for 12 diseases, namely Immune reconstitution inflammatory syndrome, Pneumocystis jiroveci pneumonia, cerebral toxoplasmosis, cytomegalovirus manifestations, candidiasis, herpes simplex virus infections, varizella zoster virus infections, progressive multifocal leucencephalopathy, cryptosporidiosis, cryptococcosis, nontuberculosis mycobacteria infections and tuberculosis. Due to the lack of evidence by randomized controlled trials, part of the guidelines reflects expert opinions. The German version was accepted by the German and Austrian AIDS Societies and was previously published by the Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF; German Association of the Scientific Medical Societies).CONCLUSION:The review presented here is a translation of a short version of the German-Austrian Guidelines of opportunistic infections in HIV patients. These guidelines are well-accepted in a clinical setting in both Germany and Austria. They lead to a similar treatment of a heterogeneous group of patients in these countries.

The purpose of this study was to compare treatment and outcome of patients with Waldenström's macroglobulinemia (WM) in four private oncology practices (PP) and a university hospital (UH) in southwest Germany. We retrospectively reviewed the charts of all patients with WM of the last two decades of four PP in Mannheim, Heidelberg, Karlsruhe, and Speyer and the Department of Hematology of the University of Heidelberg. One hundred seventy patients could be identified, 74 from PP, 96 from the UH. Median age was 63.3 years. Patients from PP were older (median 65.3 vs. 62.5 years, p = 0.01). Only 54 % of patients from PP have received treatment during the observation time, as compared to 78.1 % of the UH (p < 0.001). In PP, 35 % of treated patients have received rituximab, as compared to 62.6 % of the patients of the UH (p < 0.001). Sixty percent of treated patients of PP have received bendamustine, as compared to only 8 % of the patients of the UH (p < 0.001). Time to first treatment was significantly shorter in patients from the UH compared to PP (median 13.7 vs. 52.9 months, p = 0.05). A trend towards a better overall survival was observed for patients treated with a rituximab-containing first-line regimen. The International Prognostic Scoring System for WM had significant prognostic value. Median overall survival was 25.0 years and did not differ between PP and UH. Despite different treatment strategies between PP and UH today overall survival of patients with WM is excellent, and better than previously reported.

C. Koegl1, E. Wolf1, J. Brust2, R. Baumann3, F. Schlote4, M. Karwat5, H. Heiken6, F. Mosthaf7, S. Schoelzel8, T. Wuensche9, B. Mueck1, H. Jaeger10,11, and the 50/2010 study group 1MUC Research, Munich, Germany, 2Practice Dres. Brust/Schuster/Ploeger/Hensel, Mannheim, Germany, 3Practice Dr. Baumann, Neuss, Germany, 4Practice Dres. Lauenroth-Mai/Schlote/Schuler, Berlin, Germany, 5Practice Dr. Karwat, Munich, Germany, 6Praxis Dres. Kuhlmann/Holm/Heiken, Hannover, Germany, 7Onkology Karlsruhe, Karlsruhe, Germany, 8Allgemeinmedizin Troisdorf, Troisdorf, Germany, 9Practice Dr. Wuensche, Berlin, Germany, 10MVZ Karlsplatz-HIV Research and Clinical Care Centre, Munich, Germany, 11DAGNAE e.V., Berlin, Germany

8044 Background: No data are available on using PET-scans in HIV-HL. The goal of the present study is to analyse consecutive patients (pts) with HIV-HL who had at least one PET scan conducted during their course of primary chemotherapy (CT). Methods: In the German prospective multicenter trial pts. with HIV-HL are planned to receive 2x ABVD + 30 Gy involved field (IF) radiation (RT) for early stage (ES) favourable HL (stage I/II without risk factors), 4x BEACOPP baseline or 4x ABVD + 30 Gy IF for ES unfavourable HL, and 6-8 x BEACOPP baseline for advanced stage HL with BEACOPP being replaced by ABVD in pts with far advanced HIV-infection or poor performance status. Since the role of PET-scans is not specifically addressed in this trial FDG-PET is not routinely scheduled. However, as PET-scans are being performed on physician’s choice we retrospectively analyzed results and clinical impact of FDG-PET in this cohort of pts. Results: From 03/04 to 12/10 105 pts (median age 43.9 yrs, 8 females) were included in the trial. 23 pts (22%) had ES favourable HL, 14 (13%) ES unfavourable HL, and 68 (65%) advanced stage HL. 26 of 105 pts had a total of 37 PET/PET-CT scans done at some point during their course of treatment. FDG-PET was conducted as part of the initial staging and for response assessment in 8 and 28 cases, respectively. 1 pt had a PET-scan performed to rule out a late relapse of HL or a second malignancy. A negative FDG-PET had an impact on further management in 15 pts with additional RT being omitted in 9 pts and CT for advanced HL being terminated after 6 or 7 cycles of BEACOPP in 5 pts and 1 pt, respectively. A PET-scan performed after 2 cycles of ABVD (PET2) proved negative (neg) in 3/3 pts with 2 of those not receiving IF-RT. PET4 proved negative in 4 of 5 pts with ES-unfavourable HL with IF-RT not being given in all PET4 neg. pts. All PET2/PET4 neg. pts who did not receive IF-RT (n=6) remain disease-free after a median follow-up of 24 months. RT was also successfully omitted in 3 pts with neg. FDG-PET after 6 or 8 cycles of CT. Conclusions: Given the high negative predictive value of FDG-PET in HIV-negative HL, these preliminary data suggest that in pts with HIV-HL a negative PET-scan conducted after 2, 4 or 6-8 cycles of CT may allow the omission of IF-RT.

8035 Background: The outcome of patients (pts) with HIV-HL has improved since the introduction of highly active antiretroviral therapy (HAART). The current trial was initiated to investigate a risk adapted treatment strategy in pts with HIV-HL as established in HIV-negative pts with HL. Methods: Pts were planned to receive 2x ABVD + 30 Gy involved field (IF) radiation for early stage (ES) favourable HL (stage I/II without risk factors), 4x BEACOPP baseline + 30 Gy IF for ES unfavourable HL (extranodal involvement, large mediastinal mass, ≥ 3 lymph node areas involved), and 6-8 × BEACOPP baseline for advanced stage HL. BEACOPP should be replaced by ABVD in pts with far advanced HIV-infection. HAART was given concomitantly with chemotherapy. The primary endpoint was tolerability and treatment related mortality. Secondary endpoints include event free survival (EFS) and overall survival (OS). Results: 93 pts (7 females) were included in the trial. 18/93 pts (19%) had ES favourable HL, 13 (14%) ES unfavourable HL, and 62 (67%) advanced stage HL. 23/87 pts (26%) had a prior AIDS defining illness. The median CD4 count at HL diagnosis was 212/μ l. Grade 3/4 toxicity occurred in 69% under ABVD and 79% under BEACOPP. 4 pts with advanced stage HL died of neutropenic sepsis after the first, seventh (n=2) and eighth course of BEACOPP, respectively. So far response data are available from 78 pts. After a median follow-up of 13.5 months 19/19 pts (100%) with ES favourable HL and 11/11 pts (100%) with ES unfavourable HL achieved a CR/CRu. In pts with advanced HL the CR/CRu rate was 83% (40/48). Of 5 pts having relapsed 2 received an autologous stem cell transplant resulting in a second remission. 7 of 93 pts (8%) have died. Apart from neutropenic sepsis causes of death were progressive HL (n=2) and progressive HIV-infection (PML, n=1). The 12-months OS of the entire study population is 88.3%. EFS and OS are significantly longer in pts with ES HL than in advanced stage HL (p=0.021 and 0.047, respectively). Conclusions: In pts with HIV-HL risk-adapted CT and concomitant HAART is feasible and effective. However, pts must closely be monitored for neutropenic infections. These data suggest that the prognosis of HIV-HD may approach results achieved in the HIV-negative population with HL. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abbott Laboratories, Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, MSD, Pfizer, Schering, Vertex, Gilead Abbott Laboratories, Bristol Myers-Squibb, Boehringer Ingelheim, GlaxoSmithKline, MSD, Pfizer, Schering, Vertex, Gilead, Pfizer, Gilead, Abbott, GlaxoSmithKline, Boehringer Ingelheim Abbott Laboratories, Roche, MSD

e22115 Background: Malignancies are an essential feature of acquired immunodeficiency syndrome and human immunodeficiency virus (HIV) infection. The purpose of this study was to gather data on the epidemiology of AIDS-defining (AD) and non-AIDS-defining (NAD) malignancies in HIV-positive patients (pts) in Germany in the past decade. Methods: Study centers (all HIV-specialty clinics and ambulatory care centers in Germany, all members of the German association of medical oncologists in private practice) were contacted annually between 2000 and 2007 and asked to respond to a structured questionnaire. The questionnaire requested information on all malignancies in HIV-positive pts, tumor stage, CDC (Center for Disease Control)-stage of the HIV infection, sex, treatment and clinical course. Results: 111 centers participated in the evaluation and provided 552 evaluable data sets from 542 pts. 89% of cases were male. The majority of pts had advanced HIV-disease (CDC stage C3), but the proportion of pts with stage C3 decreased from 58% in 2000 to 36.8% in 2007. 253 (45.8%) were AD as follows: 132 Kaposi Sarcomas, 109 aggressive B-cell lymphomas, 12 invasive cervix carcinomas. The B-cell lymphomas further included 28 Burkitt's lymphomas, 30 DLBCL, 9 Castleman diseases, 8 primary cerebral lymphomas. Among the 299 cases (54.2%) of NAD malignomas were 213 solid tumors including 71 anal carcinomas (= 33.5% of all NAD malignancies) and 85 hemoblastoses including 29 Hodgkin lymphomas (= 9.6% of all NAD malignancies). The high proportion of NAD malignancies has remained constant over all observation periods, as well as the relative incidence of most of the different subentities. Interestingly, only 1 of 8 primary cerebral lymphomas has been reported after 2001. The number of pts with Hodgkin's lymphoma has increased constantly from 2000 to 2007. Conclusions: Our observations show a high incidence of NAD malignomas over the past 8 years in Germany. Anal carcinomas and Hodgkin's lymphomas in particular were markedly more prevalent in our HIV-positive cohort compared to published reports of the general population. The incidence of primary cerebral lymphomas seems to decrease, whereas the incidence of Hodgkin's lymphoma is increasing. No significant financial relationships to disclose.

Aim: For several years Nonnucleoside reverse transciptase inhibitors (NNRTIs) in antiretroviral therapy have been associated with hepatic side effects. Particularly the hepatotoxic potential of Nevirapine is well analysed today. We performed a prospective, multicenter study to compare the hepatotoxicity of Efavirenz (EFV) with that of Nevirapine (NVP) and to investigate further risk factors.Material and Methods: The study, included HIV-1-infected patients from five clinics and private medical practices in south-western Germany who initiated an antiretroviral therapy with NVP or EFV between July 1998 and December 2001. Among 296 patients in total, 151 received EFV and 145 received NVP. Laboratory tests during the course of treatment included liver enzymes, HIV-RNA and CD4 cell-count. Additionally, signs of clinical hepatitis were recorded. Hepatotoxicity was graded in the manner of Sulkowsky et al. ( 000), Who used a scale modified from that of the AIDS Clinical Trials Group.Results: Hepatitis C virus and hepatitis B virus were detected in 10.1% and 4.1% of patients, respectively. The overall rate of severe hepatotoxicity (grade 3 to 4 elevations in aspartate aminotransferase and/or alanine aminotransferase) was 2 of 151 (1.3%) in patients prescribed EFV and 3 of 145 (2.1%) in patients prescribed NVP. Mild-to-moderate hepatotoxicity (grade 2 elevation) was observed in 6.0% (EFV and 3.4% (NVP) of patients. Incidence of mild-to-moderate and severe hepatotoxicity did not differ significantly between the study groups. 3 of 14 patients (2.1%) with grade 2 elevation of liver enzymes (LEE) and 4 of 5 patients (80%) with grade 3 to 4 LEE were symptomatic. Only risk factor for the development of mild-to-moderate hepatotoxicity was hepatitis C coinfection.Conclusion: Increases of liver enzymes during therapy with NVP or EFV are not unusual, but are mostly mild-to-moderate and asymptomatic. LEE occurs just as frequent in patients prescribed ETV as in patients prescribed NVP.

OBJECTIVE:It was the main aim of this study to obtain data on the epidemiology of AIDS- and not AIDS-defined malignancies in HIV-positive persons, the results to provide an epidemiological overview and to be the basis for further research initiatives. Additionally it sought to gain an impression of the realities of treatment of patients with HIV-associated malignant tumors in Germany. PATIENTS AND METHODS:Over a period of 3 years (from the beginning of 2000 to the end of 2002) data were retrospectively collected on the incidence of malignant tumors in HIV-positive patients. A questionnaire was sent to all members of the German Working Party of Physicians in Private Practice Treating HIV-Infected Patients, all members of the Association of Haematologists and Oncologists in Private Practice, and all out-patient HIV clinics in Germany. The questionnaires were sent to a total of 949 practices/clinics. The data were collected on all AIDS- and not-AIDS-defined haematological malignancies and all AIDS- and not-AIDS-defined solid malignant tumors in HIV-positive patients, as well as on time of diagnosis of the malignancy, tumor stage, tumor treatment and response to treatment. RESULTS:380 data sets on 376 patients of 50 practices/clinics were included in the analysis (four patients had two malignant tumors). 180 malignant neoplasms (47%) were AIDS-defined: 89 Kaposi's sarcomas, 82 aggressive B-cell lymphomas and 9 invasive cervical carcinomas. The aggressive B-cell lymphomas consisted of 19 cases of Burkitt's lymphoma, 8 of Castleman's disease and 12 of primary cerebral malignant lymphoma. Of the 200 (52.6%) not-AIDS-defined malignant tumors 133 were 133 solid tumors, 40 of them anal carcinoma (20% of all not-AIDS-defined malignancies) and 67 haematological malignancies, 22 of these Hodgkin's lymphoma (11.0% of all not-AIDS-defined malignancies). The incidence of anal carcinoma is estimated to be 34 (95% CI 24-470) per 100 000 patient-years, that of Hodgkin's lymphoma 19 (95% CI 12-28) per 100 000 patient-years. CONCLUSIONS:This study indicates that over a period of 3 years there was a very high incidence of not-AIDS-defined malignancies. Of special note is the high incidence of anal carcinoma and Hodgkin's lymphoma, compared with their incidence among the entire German population.

It was the main aim of this study to obtain data on the epidemiology of AIDS- and not AIDS-defined malignancies in HIV-positive persons, the results to provide an epidemiological overview and to be the basis for further research initiatives. Additionally it sought to gain an impression of the realities of treatment of patients with HIV-associated malignant tumors in Germany.Over a period of 3 years (from the beginning of 2000 to the end of 2002) data were retrospectively collected on the incidence of malignant tumors in HIV-positive patients. A questionnaire was sent to all members of the German Working Party of Physicians in Private Practice Treating HIV-Infected Patients, all members of the Association of Haematologists and Oncologists in Private Practice, and all out-patient HIV clinics in Germany. The questionnaires were sent to a total of 949 practices/clinics. The data were collected on all AIDS- and not-AIDS-defined haematological malignancies and all AIDS- and not-AIDS-defined solid malignant tumors in HIV-positive patients, as well as on time of diagnosis of the malignancy, tumor stage, tumor treatment and response to treatment.380 data sets on 376 patients of 50 practices/clinics were included in the analysis (four patients had two malignant tumors). 180 malignant neoplasms (47%) were AIDS-defined: 89 Kaposi's sarcomas, 82 aggressive B-cell lymphomas and 9 invasive cervical carcinomas. The aggressive B-cell lymphomas consisted of 19 cases of Burkitt's lymphoma, 8 of Castleman's disease and 12 of primary cerebral malignant lymphoma. Of the 200 (52.6%) not-AIDS-defined malignant tumors 133 were 133 solid tumors, 40 of them anal carcinoma (20% of all not-AIDS-defined malignancies) and 67 haematological malignancies, 22 of these Hodgkin's lymphoma (11.0% of all not-AIDS-defined malignancies). The incidence of anal carcinoma is estimated to be 34 (95% CI 24-470) per 100 000 patient-years, that of Hodgkin's lymphoma 19 (95% CI 12-28) per 100 000 patient-years.This study indicates that over a period of 3 years there was a very high incidence of not-AIDS-defined malignancies. Of special note is the high incidence of anal carcinoma and Hodgkin's lymphoma, compared with their incidence among the entire German population.

7554 Background: The primary purpose of this study was to gather data on the epidemiology of AIDS- and non-AIDS-defining malignomas in HIV-positive patients nation-wide in Germany. The secondary objective was to obtain information on their therapy and outcomes. Methods: Surveys were conducted targeting all HIV-specialty clinics and ambulatory care centres as well as all members of the national society of oncologists (BNHO). The surveys requested information on all AIDS- and non-AIDS-defining hematological neoplasms and solid tumors over 3 years (2000–2002) in HIV-positive patients, their tumor stage, their treatments and their clinical course. Further parameters were the CDC (Center for Disease Control)-stage of the HIV-infection and for 2002 the sex of the patient. Results: 60 centres participated in the evaluation and provided 382 data sets. Two data sets were dismissed, where the diagnosis was not made within the defined time frame. Thus 380 data sets from 376 patients could be evaluated (4 patients had 2 malignomas). 180 (47.4%) were AIDS-defining as follows: 89 Kaposi Sarcomas, 82 aggressive B-cell lymphomas, 9 invasive cervix carcimomas. The B-cell lymphomas further included 19 Burkitt’s lymphomas, 8 Castleman diseases, 12 primary cerebral lymphomas. Among the 200 cases (52.6%) of non-AIDS defining malignomas were 133 solid tumors including 40 anal carcinomas (= 20.0% of all non-AIDS defining malignancies) and 67 hemoblastoses including 22 Hodgkin lymphomas (= 11% of all non-AIDS defining malignancies). Conclusions: Our observation showed an unexpected high incidence of non AIDS-defining malignomas over the 3-year time interval followed. Anal carcinomas and M. Hodgkin lymphomas in particular were markedly more prevalent in our HIV-positive cohort compared to published reports of the general population. A conservative estimate showed the incidence of Hodgkin lymphomas to be 6- to 17-times higher, and that of anal carcinomas to be 30- to 60-times elevated. No significant financial relationships to disclose.

Objective: It was the main aim of this study to obtain data on the epidemiology of AIDS- and not AIDS-defined malignancies in HIV-positive persons, the results to provide an epidemiological overview and to be the basis for further research initiatives. Additionally it sought to gain an impression of the realities of treatment of patients with HIV-associated malignant tumors in Germany.Patients and Methods: Over a period of 3 years (from the beginning of 2000 to the end of 2002) data were retrospectively collected on the incidence of malignant tumors in HIV-positive patients. A questionnaire was sent to all members of the German Working Party of Physicians in Private Practice Treating HIV-Infected Patients, all members of the Association of Haematologists and Oncologists in Private Practice, and all out-patient HIV clinics in Germany. The questionnaires were sent to a total of 949 practices/clinics. The data were collected on all AIDS- and not-AIDS-defined haematological malignancies and all AIDS- and not-AIDS-defined solid malignant tumors in HIV-positive patients, as well as on time of diagnosis of the malignancy, tumor stage, tumor treatment and response to treatment.Results: 380 data sets on 376 patients of 50 practices/clinics were included in the analysis (four patients had two malignant tumors). 180 malignant neoplasms (47%) were AIDS-defined: 89 Kaposi's sarcomas, 82 aggressive B-cell lymphomas and 9 invasive cervical carcinomas. The aggressive B-cell lymphomas consisted of 19 cases of Burkitt's lymphoma, 8 of Castleman's disease and 12 of primary cerebral malignant lymphoma. Of the 200 (52.6%) not-AIDS-defined malignant tumors 133 were 133 solid tumors, 40 of them anal carcinoma (20% of all not-AIDS-defined malignancies) and 67 haematological malignancies, 22 of these Hodgkin's lymphoma (11.0% of all not-AIDS-defined malignancies). The incidence of anal carcinoma is estimated to be 34 (95% Cl 24-470) per 100 000 patient-years, that of Hodgkin's lymphoma 19 (95% Cl 12-28) per 100 000 patient-years.Conclusions: This study indicates that over a period of 3 years there was a very high incidence of not-AIDS-defined malignancies. Of special note is the high incidence of anal carcinoma and Hodgkin's lymphoma, compared with their incidence among the entire German population.

Efavirenz und Nevirapin zählen zu den oft verwendeten Medikamenten bei HIV-Infektion. Wichtige Nebenwirkung dieser Substanzen sind Arzneimittelexantheme. In der vorliegenden Studie werden die Exantheme als häufigste Nebenwirkung beider Substanzen charakterisiert.

Efavirenz and nevirapine are frequently used drugs in antiretroviral therapy. Rashes are common side effects of these drugs. In this study, we examined the characteristics of efavirenz- and nevirapine-associated rashes. This prospective nonrandomized multicenter study included 662 HIV-infected patients (efavirenz: 325, nevirapine: 337) to determine incidence, duration, cross-reactivity, and outcome upon reexposure. Of the treated patients, 4.5% (n=30) developed rashes (nevirapine: 2.4% and efavirenz: 6.4%). In four patients treatment was not interrupted. Three patients were re-exposed to the initial drug without any side effects. Therapy with nevirapine or efavirenz does not have to be interrupted if rashes exhibit no blistering, mucosal manifestations, or systemic signs.

The non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz (EFV) and nevirapine (NVP) taken in combination with nucleoside reverse transcriptase inhibitors (NRTIs) have both shown to be just as highly effective as protease inhibitors (PIs) in reducing viral load in patients infected with HIV. Our study compares the performance of these two NNRTIs with each other. This was a non-randomized, prospective, two-arm, multi-centre trial. We evaluated all patients with an EFV- or NVP-containing antiretroviral regimen. The primary endpoint was the difference in success rates defined as a viral load of =50 copies/mL at week 48. chi(2)-tests were used for naïve and pretreated patients using intention-to-treat (ITT) and on-treatment analysis. As secondary endpoints, a viral load of =500 copies/mL and CD4 count at week 48 for naïve patients were evaluated. A Cox regression was used to adjust for prespecified covariates. We included 662 patients (NVP 337, EFV 325). The difference in success rates in the ITT analysis was 4.5% ( -11.5%, 19.0%), P=0.578. Pretreated patients with a triple therapy show a difference of 10.1 (-0.3, 20.6), P=0.056. Non-significant results appeared for all secondary analyses. In this trial, no difference between EFV and NVP in combination with NRTI backbone therapy can be shown, regarding viral load. Further randomized studies are necessary to evaluate possible differences.

Efavirenz and nevirapine are frequently used drugs in antiretroviral therapy. Rashes are common side effects of these drugs. In this study, we examined the characteristics of efavirenz- and nevirapine-associated rashes.This prospective nonrandomized multicenter study included 662 HIV-infected patients (efavirenz: 325, nevirapine: 337) to determine incidence, duration, cross-reactivity, and outcome upon reexposure.Of the treated patients, 4.5% (n=30) developed rashes (nevirapine: 2.4% and efavirenz: 6.4%). In four patients treatment was not interrupted. Three patients were reexposed to the initial drug without any side effects.Therapy with nevirapine or efavirenz does not have to be interrupted if rashes exhibit no blistering, mucosal manifestations, or systemic signs.

PURPOSE:To show Didanosin in a new formulation as a once-a-day capsula as a well-tolerated and effective HIV-therapy when used in a protease sparing regimen including genotypic resistance pattern in blood, semen and cerebrospinal fluid before and during treatment.METHOD:Two groups of 58 patients, each containing 9 patients who had not been previously treated with any antiretroviral medication, and 49 patients heavily pretreated for 3,7 (DDI group) and 2,8 (non-DDI group) years, have been followed up for at least half a year. A group of 24 patients taking a special combination of Didanosin plus Efavirenz and Stavudine have been analysed with genotypic resistance testing concerning viral load response and resistance pattern under therapy.RESULTS:Suppression of plasma HIV-1 RNA to <50 copies/mL and <500 copies/mL in the DDI group was achieved in 74% and 84% of the pretreated patients, respectively, and in 100% of the naive patients after 24 weeks. In the non-DDI group suppression was achieved in 59% and 69% of the pretreated patients, respectively, and in also 100% of the naive patients. The viral load reduction in the DDI containing regimen at week 24 was 1.7 log subset 10 for the pretreated and 3,4 log subset 10 for the naive patients. In the non-DDI group, the reduction was 1.5 for the pretreated and 4,0 for the naive patients. CD4 cell counts increased from 440 to 517 cells/microL at week 24 for the pretreated, and from 171 to 289 for the naive patients in the DDI containing regimen. In the other group, cells increased from 396 to 406 for the pretreated and from 155 to 321 for the naive patients. In each group, 12 patients discontinued treatment; 4 patients in the DDI group and 7 patients in the non-DDI group because of adverse events. There were no AIDS-defining events in the antiretroviral-treated patients in both groups. 16 patients of the special combination group (DDI, D4T and EFV) were evaluated for more than 24 weeks. Suppression of HIV-1 RNA to <50 copies /mL were found in 75% of the naive and 43% of the pretreated patients. No relevant mutations were found during treatment.CONCLUSION:The new formulation of Didanosin as a once-a-day capsula in a protease sparing regimen was well-tolerated, effective in reducing viral load and in preventing AIDS-defining events. The combination of DDI, D4T and EFV proved to be a potent therapy without developing relevant mutations.