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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002410 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Lamivudine Drug: Zidovudine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00002410
Responsible Party
Study ID Numbers ^ICMJE	281B, DMP 266-006
Study Sponsor ^ICMJE	Dupont Merck
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1998
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP