A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
2 other identifiers
interventional
200
2 countries
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
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
CompletedOctober 2, 2007
October 1, 2007
November 2, 1999
October 1, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Documented HIV infection.
- CD4 cell count of 200 - 700 cells/mm3.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
East Bay AIDS Clinic
Berkeley, California, 94705, United States
Harbor UCLA Med Ctr / Division of Immunology / N-24
Torrance, California, 90509, United States
Anderson Clinical Research
Washington D.C., District of Columbia, 20037, United States
George Washington Med Ctr / Clinical Trials Unit
Washington D.C., District of Columbia, 20037, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610, United States
Northwestern Univ
Chicago, Illinois, 60611, United States
Univ of Nebraska
Omaha, Nebraska, 68195, United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599, United States
The Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207, United States
Univ of Pennsylvania / Infectious Diseases Division
Philadelphia, Pennsylvania, 19104, 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
Hosp Regional de Ponce - Area Vieja
Ponce, 00731, Puerto Rico