Not Signed In -
Stavudine |
d4T; Zerit |
Clinical Trial: A Comparison of Epivir Plus Crixivan Combined with Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
This study is no longer recruiting patients.
|
Purpose
To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
| Condition | Treatment or Intervention |
|---|---|
| HIV Infections | Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
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
Expected Total Enrollment: 200
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
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Patients must have:
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.
Location Information
Alabama
Univ of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Florida
Infectious Disease Research Institute Inc, Tampa, Florida, 33614, United States
HIV Clinical Research Ctr, Fort Lauderdale, Florida, 33316, United States
Georgia
Advance Clinical Research, Atlanta, Georgia, 30327, United States
Louisiana
Louisiana State Univ Med Ctr / HIV Outpatient Clinic, New Orleans, Louisiana, 70112, United States
Massachusetts
Community Research Initiative of New England, Brookline, Massachusetts, 02445, United States
Boston Univ Med Ctr Hosp / Evans - 556, Boston, Massachusetts, 02118, United States
Missouri
Washington Univ School of Medicine, St. Louis, Missouri, 63108, United States
Texas
Blackstock Family Health Ctr, Austin, Texas, 76751, United States
Puerto Rico
Hosp Regional de Ponce - Area Vieja, Ponce, 00731, Puerto Rico
San Juan AIDS Program, Santurce, 00908, Puerto Rico
More Information
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002369
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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