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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002349

Collaborator

(none)

Enrollment

Locations

51.9

Duration (Months)

13.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Stavudine	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

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.

Study Start Date :

Jan 1, 1995

Actual Primary Completion Date :

May 1, 1999

Actual Study Completion Date :

May 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	San Diego Naval Hosp	San Diego	California	United States	921345000
2	Naval Med Ctr	Portsmouth	Virginia	United States	237085100
3	Northwest Med Ctr	Seattle	Washington	United States	98122