A Study of L-735,524 in HIV-Positive Children and Adolescents

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. To obtain preliminary data on antiviral activity of MK-639.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Indinavir

Criteria

Inclusion Criteria

Patients must have:

• HIV positivity.

• No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina.

• Body surface area at least 1.0 sqm.

• Consent of parent or guardian.

Prior Medication:

Allowed:

• Aerosolized pentamidine.

• Topical antifungals.

• TMP / SMX.

• AZT.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Significant hepatic disease including HBsAg or hepatitis C positivity.

• Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder.

• Significant cardiac disease including dysrhythmia or cardiomyopathy.

• Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results.

• Has a social situation that may interfere with study participation.

Concurrent Medication:

Excluded:

• Oral contraceptives.

Patients with the following prior conditions are excluded:

• History of serious allergic drug reactions.

• History of significant cardiac disease.

• Participation on another clinical trial within the past 4 weeks.

• Donated blood within the past 4 weeks.

Prior Medication:

Excluded within the past 4 weeks:

• Hematopoietic growth factors.

Excluded within the past 2 weeks:

• Antiretroviral agent other than zidovudine.

• Oral contraceptives.

• Prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and TMP/SMX.

• Any other medication unless approved by Merck clinical monitor. Current illicit drug use.