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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

August 15, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002308 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Stavudine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002308

Responsible Party

Study ID Numbers ^ICMJE

116B, AI455-900

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

. .

Information Provided By

Bristol-Myers Squibb

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP