A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002168
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
  Purpose

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.


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

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) + 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

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) + 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

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: NCT00002168

Locations
United States, California
East Bay AIDS Clinic
Berkeley, California, United States, 94705
Harbor UCLA Med Ctr / Division of Immunology / N-24
Torrance, California, United States, 90509
United States, District of Columbia
George Washington Med Ctr / Clinical Trials Unit
Washington, District of Columbia, United States, 20037
Anderson Clinical Research
Washington, District of Columbia, United States, 20037
United States, Illinois
Northwestern Univ
Chicago, Illinois, United States, 60611
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
United States, Nebraska
Univ of Nebraska
Omaha, Nebraska, United States, 68195
United States, North Carolina
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, United States, 27599
The Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Univ of Pennsylvania / Infectious Diseases Division
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Southwest Infectious Disease Association / PA
Dallas, Texas, United States, 75225
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Puerto Rico
Hosp Regional de Ponce - Area Vieja
Ponce, Puerto Rico, 00731
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002168     History of Changes
Other Study ID Numbers: 260B, BMS 002
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:
Didanosine
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
Didanosine
Zidovudine
Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Indinavir
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
Anti-HIV Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014