A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
• Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
• Ketoconazole, itraconazole, and clarithromycin.
• Concomitant systemic therapy for acute opportunistic infection or malignancy.

Excluded:

Life expectancy less than 12 months.

Prior Medication:

Excluded:

• Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
• Prior antiretroviral agent within 14 days of initiating study treatment.
• Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.

Patients must:

• Have a diagnosis of HIV infection.
• Have CD4 counts greater than or equal to 50 cell/mm3.
• Have a life expectancy greater than or equal to 12 months.
• Be post-pubescent.