- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002351
A Study of L-735,524 in HIV-Positive Children and Adolescents
June 23, 2005 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
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.
Study Type
Interventional
Enrollment
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Whitehouse Station, New Jersey, United States, 088890100
- Merck & Co Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
October 1, 1995
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Indinavir
Other Study ID Numbers
- 246A
- 026-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Indinavir sulfate
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...Withdrawn
-
Merck Sharp & Dohme LLCCompletedHIV InfectionsUnited States
-
Glaxo WellcomeCompleted
-
Glaxo WellcomeCompletedHIV InfectionsUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Glaxo WellcomeCompleted
-
Glaxo WellcomeCompleted