Last updated: 11/07/2018 18:11:30
A Phase II Trial to Assess the Preliminary Antiviral Effect, Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of APV Oral Solution in Combination with NRTIs in HIV Infected Children Below 13 Years Old
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 II Trial to Assess the Preliminary Antiviral Effect, Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of APV Oral Solution in Combination with NRTIs in HIV Infected Children Below 13 Years Old
Trial description: A Phase II Trial to Assess the Preliminary Antiviral Effect, Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of APV Oral Solution in Combination with NRTIs in HIV Infected Children Below 13 Years Old
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:
Blanche S, et al. A Phase II study of amprenavir (APV, 141W94, Agenerase) in antiretroviral-experienced children with HIV-infection. 7th Conference on Retrovirus and Opportunistic Infections. San Francisco, California, USA 30 January - 2 February 2000. Abstract 695.
Blanche et a. Pharmacokinetic and Pharmacodynamic Analysis of Amprenavir-Containing Combination Therapy in HIV-1 Infected Children. J Clin Pharmacol (United States), Nov 2004, 44(11) p1301-1308.
Randall S, et al. Amprenavir In PI-Naïve And PI-Experienced Paediatric Patients: Viral Genotypic And Phenotypic Analyses And Correlation With Treatment Outcome. 5th International Congress on Drug Therapy in HIV Infection, October 22-26, 2000 Glasgow, UK. Abstract 226.
Stein D, et al. PK/PD analysis of variables that influence antiviral response in children treated with amprenavir (APV) containing combination antiviral therapy (PROB2004). 2nd International Workshop on Clinical Pharmacology of HIV Therapy. Noordwijk, The Netherlands. April 2nd-4th 2001. Abstract 5.2.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
February 1998 to January 2001
Type
Not applicable
Phase
2
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
2001-22-01
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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