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:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002349
First received: November 2, 1999
Last updated: April 13, 2011
Last verified: April 2011
  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:


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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Infection
Communicable Diseases
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
Stavudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 19, 2014