Back to resultsA Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stavudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Complex, Stavudine
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.
Sites / Locations
- San Diego Naval Hosp
- Naval Med Ctr
- Northwest Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002349
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
May 1999 (Actual)
Study Completion Date
May 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
AIDS-Related Complex, Stavudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Stavudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
. ., .
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego Naval Hosp
City
San Diego
State/Province
California
ZIP/Postal Code
921345000
Country
United States
Facility Name
Naval Med Ctr
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
237085100
Country
United States
Facility Name
Northwest Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
background
Learn more about this trial
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
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