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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Indinavir sulfate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Merck & Co Inc

Whitehouse Station, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 9651421 (View on PubMed)

Other Identifiers

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026-01

Identifier Type: -

Identifier Source: secondary_id

246A