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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002354

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: January 1996
History of Changes
Purpose

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 Intervention
HIV Infections

Drug : Indinavir sulfate
Drug : Stavudine

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
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)

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 540

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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).

contacts and locations

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: NCT00002354

Locations

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT00002354   History of Changes  
Other Study ID Numbers: 246D  
  37  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Stavudine
HIV Protease Inhibitors
Indinavir

Additional relevant MeSH terms:
HIV Infections
Stavudine
Indinavir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.