Last updated: 11/07/2018 18:08:28
A Study to Investigate the Degree of Pharmacokinetic Interaction Between Amprenavir and Ritonavir Following Their Co-Administration to Healthy Subjects.
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 Study to Investigate the Degree of Pharmacokinetic Interaction Between Amprenavir and Ritonavir Following Their Co-Administration to Healthy Subjects.
Trial description: A Study to Investigate the Degree of Pharmacokinetic Interaction Between Amprenavir and Ritonavir Following Their Co-Administration to Healthy Subjects.
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:
D.S. Stein, B. Sadler, M. Sale , Pharmacodynamic effects of amprenavir (APV) + ritonavir (RTV) on different viral populations Pharmacology of HIV Therapy . 1st International Workshop on Clinical Pharmacology of HIV Therapy March 30-April 1, 2000 Noordwijk, the Netherlands [Poster 5.2]
M. Sale, D.S. Stein, B. Sadler Concomitant ritonavir decreases the clearance of amprenavir- a pharmacokinetic model and simulation of protease inhibitor interaction. 1st International Workshop on Clinical Pharmacology of HIV Therapy, March 30-April 1, 2000 Noordwijk, the Netherlands, [Poster 2.1].
Sadler B.M., Piliero P.J., Preston S.L., Lloyd P.P., Lou Y., Stein D. Pharmacokinetics and safety of amprenavir and ritonavir following multiple-dose, co-administration to healthy volunteers. AIDS. 2001; 15: 1009-1018.
Sadler BM, Piliero PJ, Preston SL, Lou Y, Stein DS. Pharmacokinetic (PK) Drug-Interaction Between Amprenavir (APV) and Ritonavir (RTV) in HIV-seronegative Subjects After Multiple, Oral Dosing. 7th Conference on Retroviruses and Opportunistic Infections. San Francisco, CA, 2000: abstract #77, 5 (1).
Sale M, Sadler B.M., Stein D.S. Pharmacokinetic modeling and simulations of interaction of amprenavir and ritonavir. Antimicrob Agents Chemother. 2002; 46: 746-754.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
September 1999 to October 1999
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
1999-26-10
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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