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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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.

Study NCT00002349. Last updated on August 15, 2007. Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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.

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections

Intervention ^†

Drug: Stavudine

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00002349

Organization ID

244A

Secondary IDs ^††

AI455-029

Study Sponsor ^†

Bristol-Myers Squibb

Collaborators ^††

Investigators ^†

Principal Investigator:

. ., .

Information Provided By

Bristol-Myers Squibb

Verification Date

August 2007

First Received Date ^†

November 2, 1999

Last Updated Date

August 15, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.