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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002410

Run by

Dupont Merck

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• Arizona Clinical Research Ctr Inc — Tucson, Arizona, United States
• Richard Stryker — Beverly Hills, California, United States
• Paul Cimoch — Irvine, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Kraus Med Group — Los Angeles, California, United States
• Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr — Los Angeles, California, United States
• Blick Med Associates — Stamford, Connecticut, United States
• Novum Inc — Washington D.C., District of Columbia, United States
• Bach and Godofsky — Bradenton, Florida, United States
• Community Research Initiative of South Florida — Coral Gables, Florida, United States
• Boulevard Comprehensive Care Ctr — Jacksonville, Florida, United States
• Larry Marc Bush / c/o Sally Yantis — Lake Worth, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Ctr for Quality Care — Tampa, Florida, United States
• Daniel Seekins — Tampa, Florida, United States
• Infectious Disease Research Institute — Tampa, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States
• Georgia Research Associates — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• Infectious Diseases — Indianapolis, Indiana, United States
• Univ of Kentucky Med Ctr — Lexington, Kentucky, United States
• Kansas City AIDS Research Consortium — Kansas City, Missouri, United States
• Univ of Nebraska Med Ctr / HIV Clinic — Omaha, Nebraska, United States
• Univ Med Ctr / HIV Wellness Ctr — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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