Didanosine in HIV-1-infected patients experiencing failure of antiretroviral therapy: a randomized placebo-controlled trial.

Abstract

BACKGROUND:

The antiviral efficacy of didanosine in patients experiencing virological failure is not well known.

METHODS:

A total of 168 patients (139 men and 29 women) receiving stable antiretroviral therapy with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000-100,000 copies/mL were randomly assigned to have didanosine (n=111) or placebo (n=57) added to their currently failing regimen for 4 weeks. The primary efficacy end point was the change in HIV-1 RNA level from baseline to week 4.

RESULTS:

At baseline, the median HIV-1 RNA level was 3.8 log(10) copies/mL, the median CD4 cell count was 378 cells/mm(3), and the median number of nucleoside reverse-transcriptase inhibitor-associated mutations (NAMs) was 4. At week 4, a significant decrease in the median HIV-1 RNA level was observed in the didanosine group, compared with that in the placebo group (-0.56 vs. +0.07 log(10) copies/mL, respectively) (P<.0001). A total of 33 patients (31%) in the didanosine group, compared with 3 (6%) in the placebo group, had HIV-1 RNA levels <400 copies/mL (P<.001). Significant antiviral activity of didanosine was observed in patients with up to 5 NAMs at baseline. Diarrhea occurred in 5 patients (5%) in the didanosine group and 2 patients (4%) in the placebo group.

CONCLUSIONS:

In HIV-1-infected patients experiencing failure of antiretroviral therapy, didanosine retains short-term antiviral activity.

• Authors: Jean-Michel Molina, Anne-Geneviève Marcelin, Juliette Pavie, Laurence Heripret, Corinne Merle De Boever, Martine Troccaz, Ghislaine Leleu, Vincent Calvez, AI454-176 JAGUAR Study Team
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 191 Issue 6 Pg. 840-7 (Mar 15 2005) ISSN: 0022-1899 [Print] United States
• PMID: 15717257 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-HIV Agents
• RNA, Viral
• Reverse Transcriptase Inhibitors
• HIV Reverse Transcriptase
• Didanosine

Topics

• Adult
• Aged
• Anti-HIV Agents (adverse effects, therapeutic use)
• Didanosine (adverse effects, therapeutic use)
• Double-Blind Method
• Drug Resistance, Viral (genetics)
• Drug Therapy, Combination
• Female
• HIV Infections (drug therapy, virology)
• HIV Reverse Transcriptase (genetics)
• HIV-1 (drug effects)
• Humans
• Male
• Middle Aged
• Mutation
• RNA, Viral (blood)
• Reverse Transcriptase Inhibitors (adverse effects, therapeutic use)
• Treatment Failure
• Treatment Outcome