search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors, Indinavir

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Merck & Co Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00002351
Brief Title
A Study of L-735,524 in HIV-Positive Children and Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors, Indinavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Merck & Co Inc
City
Whitehouse Station
State/Province
New Jersey
ZIP/Postal Code
088890100
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9651421
Citation
Mueller BU, Sleasman J, Nelson RP Jr, Smith S, Deutsch PJ, Ju W, Steinberg SM, Balis FM, Jarosinski PF, Brouwers P, Mistry G, Winchell G, Zwerski S, Sei S, Wood LV, Zeichner S, Pizzo PA. A phase I/II study of the protease inhibitor indinavir in children with HIV infection. Pediatrics. 1998 Jul;102(1 Pt 1):101-9. doi: 10.1542/peds.102.1.101.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs