A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002369
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
  Purpose

To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 200
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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002369

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
HIV Clinical Research Ctr
Fort Lauderdale, Florida, United States, 33316
Infectious Disease Research Institute Inc
Tampa, Florida, United States, 33614
United States, Georgia
Advance Clinical Research
Atlanta, Georgia, United States, 30327
United States, Louisiana
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston Univ Med Ctr Hosp / Evans - 556
Boston, Massachusetts, United States, 02118
Community Research Initiative of New England
Brookline, Massachusetts, United States, 02445
United States, Missouri
Washington Univ School of Medicine
St Louis, Missouri, United States, 63108
United States, Texas
Blackstock Family Health Ctr
Austin, Texas, United States, 76751
Puerto Rico
Hosp Regional de Ponce - Area Vieja
Ponce, Puerto Rico, 00731
San Juan AIDS Program
Santurce, Puerto Rico, 00908
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002369     History of Changes
Other Study ID Numbers: 260A, BMS 001
Study First Received: November 2, 1999
Last Updated: October 1, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Drug Therapy, Combination
Zidovudine
Stavudine
HIV Protease Inhibitors
CD4 Lymphocyte Count
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Indinavir
Anti-HIV Agents
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Protease Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014