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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Stavudine; Drug: Indinavir sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002354

246D

37

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).