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

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.

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002369

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

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Zidovudine Lamivudine Indinavir Indinavir Sulfate Stavudine BaseLine

U.S. FDA Resources

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

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

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
	Infectious Disease Research Institute Inc
	Tampa, Florida, United States, 33614
	HIV Clinical Research Ctr
	Fort Lauderdale, Florida, United States, 33316

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
	Community Research Initiative of New England
	Brookline, Massachusetts, United States, 02445
	Boston Univ Med Ctr Hosp / Evans - 556
	Boston, Massachusetts, United States, 02118

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

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	260A, BMS 001
First Received:	November 2, 1999
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00002369
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2008