Last updated: 11/07/2018 18:10:39
A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 141W94 and Rifabutin and 141W94 and Rifampin Following Their Co-Administration to Healthy Male Volunteers.
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 Whether There is a Pharmacokinetic Interaction Between 141W94 and Rifabutin and 141W94 and Rifampin Following Their Co-Administration to Healthy Male Volunteers.
Trial description: A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 141W94 and Rifabutin and 141W94 and Rifampin Following Their Co-Administration to Healthy Male Volunteers.
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:
Polk RE, Brophy DF, Isreal DS, Patron R, Sadler BM, Chittick GE, Symonds WT, Lou Y, Kristoff D and Stein DS. Pharmacokinetic Interaction between Amprenavir and Rifabutin or Rifampin in Healthy Males. Antimicrob Agents Chemother. 2001;45:502- 508
Polk RE, Israel DS, Patron R, Sadler BM, Chittick GE, Symonds WT, Brophy DF, Kristoff D, Bye A. Effects of the HIV-1 protease inhibitor, 141W94, and Rifampin, and Rifabutin, on P450 (CYP) 3A4 activity, as measured by the erythromycin breath test (ERMBT). Proceedings of the 35th Annual Meeting, Infectious Diseases Society of America, September 1997, San Francisco, USA. Abstract: 236.
Polk RE, Israel DS, Patron R, Sadler BM, Chittick GE, Symonds WT, Brophy DF, Kristoff D, Lou Y, Bye A. Pharmacokinetic (PK) Interaction between 141W94 and Rifabutin (RFB) and Rifampin (RFP) after Multiple-Dose Administration. Fifth conference on Retroviruses and Opportunistic Infections, February 1998, Chicago, USA. Abstract: 340.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
March 1997 to August 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
1997-14-08
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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