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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002349
First Posted: August 31, 2001
Last Update Posted: April 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
November 2, 1999
August 31, 2001
April 14, 2011
January 1995
May 1999   (Final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT00002349 on ClinicalTrials.gov Archive Site
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A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Stavudine
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 1999
May 1999   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002349
244A
AI455-029
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Bristol-Myers Squibb
Not Provided
Principal Investigator: . ., .
Bristol-Myers Squibb
April 2011

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