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


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Stavudine

d4T; Zerit


Clinical Trial: A Study of Indinavir Sulfate Given Together with Stavudine to HIV-Positive Patients

This study has been completed.

Sponsored by: Merck Research Laboratories
Information provided by: AIDS Clinical Trials Information Service

Purpose

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.

Condition Treatment or Intervention
HIV Infections
 Drug: Indinavir sulfate
 Drug: Stavudine

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study

Official Title: One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)

Eligibility

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

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).

Location Information


New Jersey
      Merck & Co Inc, Whitehouse Station,  New Jersey,  088890100,  United States

More Information

Study ID Numbers:  246D; 37
Record last reviewed:  January 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002354
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: February 22, 2005
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