A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

This study has been completed.

First Received on November 2, 1999. Last Updated on April 13, 2011 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002349

Purpose

To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection.

Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.

Condition	Intervention
HIV Infections	Drug: Stavudine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Stavudine

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:	40
Study Start Date:	January 1995
Study Completion Date:	May 1999
Primary Completion Date:	May 1999 (Final data collection date for primary outcome measure)

Detailed Description:

Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

Recent HIV infection.
No prior antiretroviral therapy.
No acute opportunistic infection at study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Intractable diarrhea.
Bilateral peripheral neuropathy.
Any other condition that would preclude study therapy.

Concurrent Medication:

Excluded:

Myelosuppressive, neurotoxic, or hepatotoxic drugs.

Patients with the following prior condition are excluded:

History of bilateral peripheral neuropathy.

Prior Medication:

Excluded:

Prior antiretroviral therapy.
Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002349

Locations

United States, California
San Diego Naval Hosp
San Diego, California, United States, 921345000
United States, Virginia
Naval Med Ctr
Portsmouth, Virginia, United States, 237085100
United States, Washington
Northwest Med Ctr
Seattle, Washington, United States, 98122

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Principal Investigator:

. ., .

More Information

Additional 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

Publications:

Katlama C, Molina JM, Rozenbaum W, Valantin MA, Modai J, Chauveau E, Ngo Van P, Gres JJ. Stavudine ( D4T ) in HIV infected patients with CD4 less than 350/mm3: results of a double-blind randomized placebo controlled study. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:89

ClinicalTrials.gov Identifier:	NCT00002349 History of Changes
Other Study ID Numbers:	244A, AI455-029
Study First Received:	November 2, 1999
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

AIDS-Related Complex
Stavudine

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
Antiviral Agents

Stavudine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012