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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Stavudine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stavudine, HIV Protease Inhibitors, Indinavir

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Merck & Co Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00002354
Brief Title
A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stavudine, HIV Protease Inhibitors, Indinavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
540 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Merck & Co Inc
City
Whitehouse Station
State/Province
New Jersey
ZIP/Postal Code
088890100
Country
United States

12. IPD Sharing Statement

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

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