Last updated: 11/07/2018 16:11:18
An Open-Label, Single-Arm Study to Assess the Effect of Efavirenz (600mg QD) on Steady-State Plasma Amprenavir Pharmacokinetics Following Co-Administration with AGENERASE (1200mg QD), Ritonavir (300mg QD), Abacavir (300mg BID), and Lamivudine (150mg BID) in Adult HIV-Infected Subjects.
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: An Open-Label, Single-Arm Study to Assess the Effect of Efavirenz (600mg QD) on Steady-State Plasma Amprenavir Pharmacokinetics Following Co-Administration with AGENERASE (1200mg QD), Ritonavir (300mg QD), Abacavir (300mg BID), and Lamivudine (150mg BID) in Adult HIV-Infected Subjects.
Trial description: An Open-Label, Single-Arm Study to Assess the Effect of Efavirenz (600mg QD) on Steady-State Plasma Amprenavir Pharmacokinetics Following Co-Administration with AGENERASE (1200mg QD), Ritonavir (300mg QD), Abacavir (300mg BID), and Lamivudine (150mg BID) in Adult HIV-Infected 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:
Abstract: An assessment of plasma amprenavir (apv) pharmacokinetics (pk) following long-term administration of agenerase and low dose ritonavir (rtv) qd in hiv-infected adult subjects (apv20001 and col30500). Wood, R. , Wire, M. B. , Lancaster, T. , Lou, Y. , Orrell, Catherine , and Scott, T. 4th International Workshop on Clinical Pharmacology of HIV Therapy 3/27/2003 Cannes; France
Abstract: an assessment of plasma amprenavir (apv) pharmacokinetics (pk) following administration of agenerase (apv) and low dose ritonavir (rtv) qd in combination with efavirenz (efv) in hiv-infected adult subjects (col30500) - m.b. wire. Wood, R. 1, Wire, M. B. 2, Lancaster, T. 2, Lou, Y. 2, Levesque, K. 2, Naderer, O. 2, and Scott, T. 2 4th International Workshop on Clinical Pharmacology of HIV Therapy 3/27/2003 Cannes; France
Wood R, Wire M B, Lancaster CT, Lou Y, Levesque K, Naderer OJ, Scott TR. An assessment of plasma Amprenavir (APV) Pharmacokinetics (PK) following long-term administration of Agenerase (AGN) and low dose Ritonavir (RTV) QD in HIV-infected adult subjects (APV20001 and COL30500). 3rd International Workshop on Clinical Pharmacology of HIV Therapy, April 11-13, 2002. Washington, DC. Abstract 2.2.
Wood R, Wire M-B, Lancaster CT, Lou Y, Orrell C, Scott TR. An assessment of plasma Amprenavir (APV) Pharmacokinetics (PK) following administration of Agenerase (AGN) and low dose Ritonavir (RTV) QD in combination with Efavirenz (EFZ) in HIV-infected adult subjects (COL30500). 3rd International Workshop on Clinical Pharmacology of HIV Therapy, April 11-13, 2002. Washington, DC. Abstract 2.6.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
June 2001 to July 2001
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
2001-24-07
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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