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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of L-735,524 in HIV-Positive Children and Adolescents
Official Title ^ICMJE	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
Brief 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.
Detailed Description	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.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	10 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002351
Responsible Party
Study ID Numbers ^ICMJE	246A, 026-01
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	October 1995
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP