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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002351

Run by

Merck Sharp & Dohme LLC

People needed

12

Last updated by the study team

2005-06-24

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Merck & Co Inc — Whitehouse Station, New Jersey, United States

Full record on ClinicalTrials.gov

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