Shaefer M, Eron J, Yetzer E, Ruane P, Becker S, Sawyerr G, Graham N; International Conference on AIDS.
Int Conf AIDS. 1998; 12: 55 (abstract no. 12220).
UNC-Chapel Hill, RTP, USA.
OBJECTIVES: To show that in HIV-infected patients Combivir BID in combination with a PI is not different than a conventional regimen of 3TC, ZDV and a PI as measured by HIV-1 RNA levels over time. To compare the number of patients that attain undetectable HIV-1 RNA levels below the limit of detection, < 400 copies/mL. DESIGN: An open-label, randomized, parallel-group study to enroll 240 patients stable on a regimen of 3TC 150 mg BID, ZDV 600 mg daily and a PI, with HIV RNA < 10,000 c/mL and CD4+ cell count > or = 300/mm3. Patients are stratified by their current PI and then randomized to receive their PI and either Combivir or 3TC and ZDV separately. Patients will be followed for 16 weeks, or until they reach a study endpoint defined as an HIV-1 RNA increase of > 0.5log10 above baseline. Compliance data will be collected and correlated with viral load results. RESULTS: To date, 97 patients have been randomized to Combivir and 95 to 3TC and ZDV (88% male). PI's on entry were as follows: 62% indinavir, 18% nelfinavir, 10% saquinavir and 9% ritonavir. Four patients reached a viral load endpoint, HIV-1 RNA increase of > 0.5log10 above baseline, one in the Combivir + PI arm and three in the 3TC, ZDV + PI arm. TABULAR DATA, SEE abstract VOLUME CONCLUSION: Preliminary data suggest that subjects taking Combivir + a PI were more likely to have HIV-1 RNA viral load below the limit of detection than subjects taking 3TC and ZDV separately with a PI. Correlation of compliance data with viral load will be presented.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- CD4 Lymphocyte Count
- Combivir
- Drug Combinations
- HIV
- HIV Infections
- HIV Protease
- HIV Protease Inhibitors
- Humans
- Indinavir
- Lamivudine
- Male
- Nelfinavir
- Protease Inhibitors
- Viral Load
- Zidovudine
Other ID:
UI: 102227248
From Meeting Abstracts