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A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002354
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)
The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.
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Interventional
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Masking: Double
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.

Patients must have:

  • HIV infection.
  • CD4 count 50 - 500 cells/mm3.
  • Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.
  • No active opportunistic infection or visceral Kaposi's sarcoma.

NOTE:

  • Patients with hemophilia may be enrolled at discretion of investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Symptomatic neuropathy.
  • Acute hepatitis.

Concurrent Medication:

Excluded:

  • Antiretrovirals other than specified in protocol.
  • Chronic therapy for an active opportunistic infection.
  • Immunosuppressive therapy.

Prior Medication:

Excluded:

  • Any prior protease inhibitor or d4T.
  • Any nucleoside analogs within 2 weeks prior to study entry.
  • Investigational agents or immunomodulators within 30 days prior to study entry.

Required:

  • More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002354
246D
37
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Merck Sharp & Dohme Corp.
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NIH AIDS Clinical Trials Information Service
January 1996

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