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Home > "A" Clinical Trials Conditions > A Study of L-735,524 in HIV-Positive Children and Adolescents  A Study of L-735,524 in HIV-Positive Children and Adolescents
A Study of L-735,524 in HIV-Positive Children and Adolescents
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 10 Years/18 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 12
Location and Contact Information:
Merck & Co Inc
Whitehouse Station, New Jersey, 088890100
United States
Additional Information:
Study ID Numbers: 246A; 026-01
Study Start Date:
Record last reviewed: October 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002351
Other Hiv Infections Studies:
1. Psychosocial Correlates and Coping Strategies Associated with Long-Term Survival of HIV-Infected Children
2. An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV
3. Measuring HIV Quality of Care
4. Evaluating Immune Function Tests in People with HIV
5. Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects
Related Studies:
Other HIV Infections Clinical Trials
Other New Jersey Clinical Trials
Other Whitehouse Station Clinical Trials
A Study of L-735,524 in HIV-Positive Children and Adolescents
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