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

NCT00002351 | Completed Phase 1

• 2 other identifiers: 246A026-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; HIV Protease Inhibitors; Indinavir

Interventions

Indinavir sulfate DRUG

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Merck & Co Inc

Whitehouse Station, New Jersey, 088890100, United States

Location

Related Publications (1)

• 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.

  PMID: 9651421 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Indinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1995-10

Locations

US (1)