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Home > "A" Clinical Trials Conditions > A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients  A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Dupont Merck ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment:
Location and Contact Information:
Montrose Clinic
Houston, Texas, 77006
United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985400
United States
Diagnostic Clinic of San Antonio
San Antonio, Texas, 78229
United States
UT-Health Science Ctr
Houston, Texas, 77030
United States
Community Research Initiative on AIDS
New York City, New York, 10001
United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111
United States
Blick Med Associates
Stamford, Connecticut, 06901
United States
Javier O Morales Ramirez
San Juan, , 00909
Puerto Rico
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
United States
Bach and Godofsky
Bradenton, Florida, 34205
United States
Division of Infectious Disease / Dept of Internal Medicine
Dallas, Texas, 752359113
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Novum Inc / Pharmaceutical Research Services
Seattle, Washington, 98122
United States
Research Services 2000 Inc
Dallas, Texas, 75208
United States
Daniel Seekins
Tampa, Florida, 33614
United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
United States
Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
Los Angeles, California, 90059
United States
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Infectious Diseases Associates
Milwaukee, Wisconsin, 53215
United States
Infectious Disease Research Institute
Tampa, Florida, 33614
United States
Infectious Diseases
Indianapolis, Indiana, 46202
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Novum Inc
Washington D.C., District of Columbia, 20037
United States
The Miriam Hosp
Providence, Rhode Island, 02906
United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
Phoenix Body Positive
Phoenix, Arizona, 85016
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, 27157
United States
Research Services 2000 Inc
Ft. Worth, Texas, 76103
United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
Paul Cimoch
Irvine, California, 92618
United States
Ctr for Quality Care
Tampa, Florida, 33609
United States
Clinical Directors Network / HIV/AIDS Program Manager
New York City, New York, 10011
United States
Georgia Research Associates
Atlanta, Georgia, 30342
United States
Larry Marc Bush / c/o Sally Yantis
Lake Worth, Florida, 33463
United States
Richard Stryker
Beverly Hills, California, 90210
United States
Oyster Point Med Specialists
Newport News, Virginia, 23606
United States
Remington-Davis Inc
Columbus, Ohio, 43215
United States
Univ Med Ctr / HIV Wellness Ctr
Las Vegas, Nevada, 89102
United States
Kraus Med Group
Los Angeles, California, 90036
United States
Additional Information:
Study ID Numbers: 281B; DMP 266-006
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002410
Other Hiv Infections Studies:
1. A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
2. Safety and efficacy of BAY 50-4798 in patients with HIV infection
3. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
4. A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
5. A Phase I Study of Methotrexate for HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
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