Last updated: 11/07/2018 18:10:15
A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Pharmacokinetics and Tolerability of Single, Oral Doses of 141W94 in HIV-Infected Children.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Pharmacokinetics and Tolerability of Single, Oral Doses of 141W94 in HIV-Infected Children.
Trial description: A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Pharmacokinetics and Tolerability of Single, Oral Doses of 141W94 in HIV-Infected Children.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Sadler BM, Yogev R, Kovacs A, Pilati-Stevens T, Hetherington S, Khoury M, Homan J, Fonkin D, Gayle P. Pharmacokinetics of 141W94 After Single Dose Administration in HIV-Infected Children. Sixth European Conference on Clinical Aspects and Treatment of HIV-Infection, 11-15 October 1997, Hamburg, Germany, Abstract 330.
Yogev R, Kovacs A, Chadwick EG, Homans JD, Lou Y, Symonds W. Single-dose safety and pharmacokinetics of amprenavir (141W94), a human immunodeficiency virus type 1 (HIV-1) protease inhibitor, in HIV-infected children. Antimicrob Agents Chemother. 2005;49: 336-341.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
November 1996 to June 1997
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1997-18-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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