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.
Javier O Morales Ramirez, San Juan 00909, Puerto Rico
Phoenix Body Positive, Phoenix, Arizona 85016, United States
Arizona Clinical Research Ctr Inc, Tucson, Arizona 85712, United States
Paul Cimoch, Irvine, California 92618, United States
Richard Stryker, Beverly Hills, California 90210, United States
AIDS Healthcare Foundation, Los Angeles, California 90027, United States
Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr, Los Angeles, California 90059, United States
Kraus Med Group, Los Angeles, California 90036, United States
Blick Med Associates, Stamford, Connecticut 06901, United States
Novum Inc, Washington, District of Columbia 20037, United States
Treasure Coast Infectious Disease Consultants, Vero Beach, Florida 32960, United States
Infectious Disease Research Institute, Tampa, Florida 33614, United States
Bach and Godofsky, Bradenton, Florida 34205, United States
Boulevard Comprehensive Care Ctr, Jacksonville, Florida 32209, United States
Daniel Seekins, Tampa, Florida 33614, United States
Ctr for Quality Care, Tampa, Florida 33609, 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
Community Research Initiative of South Florida, Coral Gables, Florida 33146, United States
Med College of Georgia, Augusta, Georgia 30912, United States
Georgia Research Associates, Atlanta, Georgia 30342, 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
Division of Infectious Disease / Dept of Internal Medicine, Dallas, Texas 752359113, United States
UT-Health Science Ctr, Houston, Texas 77030, United States
Diagnostic Clinic of San Antonio, San Antonio, Texas 78229, United States
Montrose Clinic, Houston, Texas 77006, United States
Research Services 2000 Inc, Fort Worth, Texas 76103, United States
Research Services 2000 Inc, Dallas, Texas 75208, 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
