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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002351
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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 Intervention Phase
HIV Infections Drug: Indinavir sulfate Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 12
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002351


Locations
United States, New Jersey
Merck & Co Inc
Whitehouse Station, New Jersey, United States, 088890100
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002351     History of Changes
Other Study ID Numbers: 246A
026-01
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: October 1995

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
HIV Protease Inhibitors
Indinavir

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Indinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents