A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug); Didanosine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb
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.
Clinical Details
Official title: 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
Study design: Treatment, Parallel Assignment, Safety Study
Detailed description:
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
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Hosp Regional de Ponce - Area Vieja, Ponce 00731, Puerto Rico
Harbor UCLA Med Ctr / Division of Immunology / N-24, Torrance, California 90509, United States
East Bay AIDS Clinic, Berkeley, California 94705, United States
George Washington Med Ctr / Clinical Trials Unit, Washington, District of Columbia 20037, United States
Anderson Clinical Research, Washington, District of Columbia 20037, United States
Northwestern Univ, Chicago, Illinois 60611, United States
Chicago Ctr for Clinical Research, Chicago, Illinois 60610, 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
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Last updated: October 1, 2007
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