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

This study has been completed.

Sponsored by: Merck
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002351
  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 I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Indinavir    Indinavir Sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Pharmacokinetics Study
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

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
Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002351

Locations
United States, New Jersey
Merck & Co Inc    
      Whitehouse Station, New Jersey, United States, 088890100

Sponsors and Collaborators
Merck
  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)
 

Study ID Numbers:   246A, 026-01
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002351
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Indinavir
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008




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