A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs - Full Text View

Purpose

To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.

Condition	Intervention
HIV Infections	Drug: Stavudine

MedlinePlus related topics:

AIDS

Drug Information available for:

Stavudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety Study

Official Title:	A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With HIV Infection Who Have Failed or Are Intolerant of Alternative Antiretroviral Therapy

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV positivity with CD4 count < 300 cells/mm3.
Intolerance to or failure on approved antiretroviral therapy.
Ability to provide informed consent (of parent or guardian if appropriate).

NOTE:

Incarcerated persons may be eligible to participate.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Grade 2 or worse disease-related peripheral neuropathy.
Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI).
Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment.
Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol).

Strongly discouraged:

AZT, ddI, ddC, and other antiretroviral agents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002308

Locations


United States, New Jersey
	Bristol - Myers Squibb Co
	Princeton, New Jersey, United States, 085434500

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Principal Investigator:	. .	.

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:	116B, AI455-900
First Received:	November 2, 1999
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00002308
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Stavudine

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Communicable Diseases

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002308