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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002351
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1995

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002351 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
Drug: Indinavir sulfate
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
Not Provided

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.
Both
10 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002351
246A, 026-01
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
October 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP