A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
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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.
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
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Ages Eligible for Study:
13 Years to 60 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Life expectancy less than 12 months.
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.
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.