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Home > "A" Clinical Trials Conditions > A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients  A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
Details: 100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir). Patients will be treated for 48 weeks.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - CD4 cell count of 200 - 700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.
Total Enrollment: 200
Location and Contact Information:
The Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
United States
Univ of Nebraska
Omaha, Nebraska, 68195
United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599
United States
Northwestern Univ
Chicago, Illinois, 60611
United States
Anderson Clinical Research
Washington D.C., District of Columbia, 20037
United States
Southwest Infectious Disease Association / PA
Dallas, Texas, 75225
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Harbor UCLA Med Ctr / Division of Immunology / N-24
Torrance, California, 90509
United States
East Bay AIDS Clinic
Berkeley, California, 94705
United States
Univ of Pennsylvania / Infectious Diseases Division
Philadelphia, Pennsylvania, 19104
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
United States
George Washington Med Ctr / Clinical Trials Unit
Washington D.C., District of Columbia, 20037
United States
Hosp Regional de Ponce - Area Vieja
Ponce, , 00731
Puerto Rico
Additional Information:
Study ID Numbers: 260B; BMS 002
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002168
Other Hiv Infections Studies:
1. A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
2. Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC
3. Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
4. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease
5. The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
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