A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002354
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 540
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Merck & Co Inc — Whitehouse Station, New Jersey, United States
Full record on ClinicalTrials.gov
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