Clinical trial NCT00002351: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
HIV Protease Inhibitors
Indinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Whitehouse Station
country: United States
facility: Merck & Co Inc
state: New Jersey
Study officials:
References:
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.