A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb
Summary
To evaluate the tolerance, and comparative virologic and immunologic effects of the two
combination regimens.
Clinical Details
Official title: An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/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) + Epivir (Lamivudine) + 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
San Juan AIDS Program, Santurce 00908, Puerto Rico
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States
HIV Clinical Research Ctr, Fort Lauderdale, Florida 33316, United States
Advance Clinical Research, Atlanta, Georgia 30327, United States
Louisiana State Univ Med Ctr / HIV Outpatient Clinic, New Orleans, Louisiana 70112, United States
Community Research Initiative of New England, Brookline, Massachusetts 02445, United States
Boston Univ Med Ctr Hosp / Evans - 556, Boston, Massachusetts 02118, United States
Washington Univ School of Medicine, St Louis, Missouri 63108, United States
Blackstock Family Health Ctr, Austin, Texas 76751, 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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