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
2 other identifiers
interventional
N/A
2 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
41 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dupont Mercklead
Study Sites (41)
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712, United States
Richard Stryker
Beverly Hills, California, 90210, United States
Paul Cimoch
Irvine, California, 92618, United States
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Kraus Med Group
Los Angeles, California, 90036, United States
Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
Los Angeles, California, 90059, United States
Blick Med Associates
Stamford, Connecticut, 06901, United States
Novum Inc
Washington D.C., District of Columbia, 20037, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146, United States
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209, United States
Larry Marc Bush / c/o Sally Yantis
Lake Worth, Florida, 33463, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Ctr for Quality Care
Tampa, Florida, 33609, United States
Daniel Seekins
Tampa, Florida, 33614, United States
Infectious Disease Research Institute
Tampa, Florida, 33614, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
Georgia Research Associates
Atlanta, Georgia, 30342, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Infectious Diseases
Indianapolis, Indiana, 46202, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111, United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985400, United States
Univ Med Ctr / HIV Wellness Ctr
Las Vegas, Nevada, 89102, United States
Community Research Initiative on AIDS
New York, New York, 10001, United States
Clinical Directors Network / HIV/AIDS Program Manager
New York, New York, 10011, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157, United States
Remington-Davis Inc
Columbus, Ohio, 43215, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
The Miriam Hosp
Providence, Rhode Island, 02906, United States
Research Services 2000 Inc
Dallas, Texas, 75208, United States
Division of Infectious Disease / Dept of Internal Medicine
Dallas, Texas, 752359113, United States
Research Services 2000 Inc
Fort Worth, Texas, 76103, United States
Montrose Clinic
Houston, Texas, 77006, United States
UT-Health Science Ctr
Houston, Texas, 77030, United States
Diagnostic Clinic of San Antonio
San Antonio, Texas, 78229, United States
Oyster Point Med Specialists
Newport News, Virginia, 23606, United States
Novum Inc / Pharmaceutical Research Services
Seattle, Washington, 98122, United States
Infectious Diseases Associates
Milwaukee, Wisconsin, 53215, United States
Javier O Morales Ramirez
San Juan, 00909, Puerto Rico