Trial | NCT00002349  Report issue

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    stavudine ...

  • Study Participants

    40
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.
Study Started
Jan 31
1995
Primary Completion
May 31
1999
Study Completion
May 31
1999
Last Update
Apr 14
2011
Estimate

Drug Stavudine

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.
No Results Posted