A Study of L-735,524 in HIV-Positive Children and Adolescents
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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.
Condition or disease
Drug: Indinavir sulfate
Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to 8 hours following the first and last dose. Urine samples are collected on days 1 and 5.
An Open-Labeled, Multiple Dose, Multicenter Study to Investigate the Safety, Tolerability, and Plasma Concentration Profile of L-735,524 Capsules in HIV-Seropositive Older Children and Adolescent Patients
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Ages Eligible for Study:
10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
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.
TMP / SMX.
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.
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.
Excluded within the past 4 weeks:
Hematopoietic growth factors.
Excluded within the past 2 weeks:
Antiretroviral agent other than zidovudine.
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.
Mueller BU, Smith S, Sleasman J, Nelson RP Jr, Meyer C, Deutsch P, Zwerski S, Mistry G, Sei S, Wood L, Zeichner S, Brouwers P, Jarosinski P, Lewis L, Pizzo PA. A phase I/II study of the protease inhibitor indinavir (MK-0639) in children with HIV infection. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):37 (abstract no WeB554)