didanosine and Erythema

To study the addition of a third human immunodeficiency virus type 1 (HIV-1) reverse transcriptase inhibitor, nevirapine, to the combination of zidovudine and didanosine.. A 48-week, randomized, double-blind, placebo-controlled trial at 16 AIDS (acquired immunodeficiency syndrome) Clinical Trials Units.. 398 adults who had HIV-1 infection, had 350 or fewer CD4+ T lymphocytes/mm3, and had had more than 6 months of previous nucleoside therapy.. 1) Either nevirapine or placebo (200 mg/d for 2 weeks, then 400 mg/d thereafter) and 2) open-label zidovudine (600 mg/d) and didanosine (400 mg/d for patients weighing > or = 60 kg).. CD4+ T lymphocyte counts, time to first HIV-1 disease progression event or death, adverse events, and nevirapine levels in plasma samples taken at random were measured in all patients. Plasma levels of HIV-1 RNA HIV-1 infectivity titer in peripheral blood mononuclear cells; serum p24 antigen levels; and plasma levels of zidovudine and didanosine were measured in patients enrolled at half the study sites.. After 48 weeks of study treatment the patients assigned to the triple-combination regimen (nevirapine, zidovudine, and didanosine) had an 18% higher mean absolute CD4 cell count (95% Cl, 7% to 29%; P = 0.001), a 0.32 log10 lower mean infectious HIV-1 titer in peripheral blood mononuclear cells (Cl, 0.05 to 0.59 log10 infectious units per million cells; P = 0.023), and a 0.25 log10 lower mean plasma HIV-1 RNA level (Cl, 0.03 to 0.48 log10 RNA copies/mL; P = 0.028) than did patients assigned to the double-combination regimen (zidovudine and didanosine). Severe rashes were more common among patients assigned to receive the triple combination (9% compared with 2%; P = 0.002). Risk for disease progression did not differ between the two groups (relative hazard of the triple-combination group, 1.24 [Cl, 0.75 to 2.06]; P > 0.2), although the study had only moderate power to detect a major difference.. Adding nevirapine to zidovudine and didanosine improved the long-term immunologic and virologic effects of therapy and was associated with severe rash among the patients studied, who had had extensive previous therapy. These results support 1) the continuing development of combinations of more than two antiretroviral drugs to increase and prolong HIV-1 suppression and 2) the potential utility of nevirapine in combination regimens.

Topics: Adult; CD4 Lymphocyte Count; Didanosine; Disease Progression; Double-Blind Method; Drug Therapy, Combination; Erythema; Female; HIV Infections; HIV-1; Humans; Male; Nevirapine; Prospective Studies; Pyridines; Reverse Transcriptase Inhibitors; RNA, Viral; Zidovudine

Preliminary results of ACTG 241 have been released. This study compared the triple therapy of nevirapine plus ddI and AZT against the double combination of ddI and AZT. Preliminary results show participants taking the triple combination had CD4 counts and CD4 percentages that were roughly equivalent to the baseline values. In contrast, the double combination experienced a 25 percent decline in both values. There were about the same number of deaths and disease progressions in both groups. The clinical benefit of the triple combination is still unclear despite the CD4 counts and the lowering of the amount of viral load.

Topics: Antiviral Agents; CD4 Lymphocyte Count; Clinical Trials as Topic; Didanosine; Drug Therapy, Combination; Erythema; HIV Infections; HIV-1; Humans; Nevirapine; Pyridines; Virus Replication; Zidovudine

Topics: Adult; Didanosine; Erythema; Foot Dermatoses; Hand Dermatoses; HIV Infections; Humans; Male; Product Surveillance, Postmarketing