Last updated: 11/07/2018 18:11:11
A Phase III, Open Label Trial to Evaluate the Safety, Antiviral Efficacy and Pharmacokinetics of 141W94 Plus Current Therapy in HIV-1 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 III, Open Label Trial to Evaluate the Safety, Antiviral Efficacy and Pharmacokinetics of 141W94 Plus Current Therapy in HIV-1 Infected Children.
Trial description: A Phase III, Open Label Trial to Evaluate the Safety, Antiviral Efficacy and Pharmacokinetics of 141W94 Plus Current Therapy in HIV-1 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:
Abstract: Virological response to amprenavir combination therapy in PI-experienced paediatric patients: association with distinct baseline hiv-1 protease variants - study proab3004. Klein, A, Maguire, M F, Paterson, D, Nacci, P, Mustafa, N, Yeo, J, Snowden, W, and Kleim, J P Third International Workshop on Salvage Therapy for HIV Infection 4/12/2000 Chicago, IL; USA
Church et al. A Phase III study of amprenavir (APV, Agenerase) in protease inhibitor naïve and expereinced HIV infected children and adolescents. 7th Conference on Retrovirus and Opportunistic Infections. San Francisco, California, USA 30 January - 2 February 2000. Abstract 693.
Medical condition
Infection, Human Immunodeficiency Virus I
Product
amprenavir
Collaborators
Not applicable
Study date(s)
February 1998 to February 2000
Type
Not applicable
Phase
3
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
2000-15-02
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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