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:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002349
First received: November 2, 1999
Last updated: April 13, 2011
Last verified: April 2011
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Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Stavudine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Stavudine
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
| Estimated Enrollment: | 40 |
| Study Start Date: | January 1995 |
| Study Completion Date: | May 1999 |
| Primary Completion Date: | May 1999 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002349
Locations
| United States, California | |
| San Diego Naval Hosp | |
| San Diego, California, United States, 921345000 | |
| United States, Virginia | |
| Naval Med Ctr | |
| Portsmouth, Virginia, United States, 237085100 | |
| United States, Washington | |
| Northwest Med Ctr | |
| Seattle, Washington, United States, 98122 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Principal Investigator: | . ., . | . |
More Information
Additional Information:
Publications:
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
| ClinicalTrials.gov Identifier: | NCT00002349 History of Changes |
| Other Study ID Numbers: | 244A, AI455-029 |
| Study First Received: | November 2, 1999 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
AIDS-Related Complex Stavudine |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Antiviral Agents |
Stavudine Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 22, 2013