A Study of L-735,524 in HIV-Positive Children and Adolesc... | NCT00002351

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

NCT00002351

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Phase 1

Conditions

HIV Infections

Interventions

Indinavir sulfate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
026-01

Status Module

Record Verification Date

Oct 1995

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Indinavir sulfate	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Merck & Co Inc		Whitehouse Station	New Jersey	088890100	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9651421	Background	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.

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome
D000386	AIDS-Related Complex

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds