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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002351
• Other study ID #: 246A
• Secondary ID: 026-01
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: October 1995
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

Locations

Country	Name	City	State
United States	Merck & Co Inc	Whitehouse Station	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)