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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002351

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors, Indinavir

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.

Interventions

DRUGIndinavir sulfate

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026