A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients (NCT00002354) | Clinical Trial Compass
CompletedNot Applicable
A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
United States540 participants
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).