AEGiS-05CROI: Combivir, a fixed formulation of lamivudine (3TC) 150 mg and zidovudine (ZDV) 300 mg, given bid plus a protease inhibitor (PI) compared to 3TC 150 mg BID and ZDV 200 mg TID plus a PI.

5th Conference on Retroviruses and Opportunistic Infections

Chicago, IL - February 1-5, 1998

Combivir, a fixed formulation of lamivudine (3TC) 150 mg and zidovudine (ZDV) 300 mg, given bid plus a protease inhibitor (PI) compared to 3TC 150 mg BID and ZDV 200 mg TID plus a PI.

Conf Retroviruses Opportunistic Infect 1998 Feb 1-5; 5th:151 (abstract no. 387c)

Eron J, Yetzer E, Poertz D, Ruane P, Becker S, Graham N, Snidow J, Fisher R, Sawyerr G, Shaefer M; University of North Carolina, Chapel Hill, NC.

OBJECTIVE: 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. Design: An open-label, randomized, parallel-group study to enroll 320 patients stable on a regimen of 3TC 150 mg BID, ZDV 600 mg daily and a PI, with HIV RNA less than 10,000 c/mL and CD4+ cell count greater than or equal to 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 wil1 be followed for 16 weeks, or until they reach a study endpoint defined as an HIV RNA increase of greater than 0.5 log₁₀ above baseline.

RESULTS: To date, 46 patients have been randomized to Combivir and 50 to 3TC and ZDV (88% male). PI's on entry were as follows: 62% indinavir, 18% nelfinavir, 10% saquinavir and 9% ritonavir. (Table: see text)

CONCLUSION: Preliminary data suggest similar effects in patients receiving therapy with Combivir plus a PI compared with 3TC, ZDV plus a PI as measured by the number of virologic failures over an 8 week period. Full data and analysis of adherence with each regimen will be presented.

Keywords: AEGIS, Lamivudine, Zidovudine, Indinavir, Anti-HIV Agents, CD4 Lymphocyte Count, Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, Drug Combinations, Nelfinavir, Sulfonic Acids, Protease Inhibitors, HIV Infections, 4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic, Acid, HIV, Combivir, 4-trimethylammonium-4'-isothiocyanostilbene-2,2'-disulfonic, acid, 4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate, Male, Human, AIDS

1998-02-01
387c

Copyright © 1998 - Foundation for Retrovirology and Human Health (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed from National Library of Medicine.