Stavudine |
d4T; Zerit |
Clinical Trial: A Study of Indinavir Sulfate Given Together with Stavudine to HIV-Positive Patients
This study has been completed.
|
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
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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