Last updated: 11/07/2018 16:33:40
A 24-week, Randomized, Open-Label, Multicenter Trial to Compare the Safety and Efficacy of the Licensed AGENERASE Dose (1200mg BID) to a Lower AGENERASE Dose (600mg BID) in the Presence of Norvir (100mg BID) when Combined with Other Background Antiretroviral Drugs in HIV-1 Infected 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 24-week, Randomized, Open-Label, Multicenter Trial to Compare the Safety and Efficacy of the Licensed AGENERASE Dose (1200mg BID) to a Lower AGENERASE Dose (600mg BID) in the Presence of Norvir (100mg BID) when Combined with Other Background Antiretroviral Drugs in HIV-1 Infected Subjects.
Trial description: A 24-week, Randomized, Open-Label, Multicenter Trial to Compare the Safety and Efficacy of the Licensed AGENERASE Dose (1200mg BID) to a Lower AGENERASE Dose (600mg BID) in the Presence of Norvir (100mg BID) when Combined with Other Background Antiretroviral Drugs in HIV-1 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:
Nadler J, Gathe J, Pollard R, Richmond G, Liao Q, Lancaster T, Griffith S, Pappa K, Hernandez. Efficacy and safety of amprenavir (APV)/ritonavir (RTV) 600/100mg BID compared to APV 1200mg BID in ART-experienced and naïve subjects: ESS40011. XIV International AIDS Conference, Barcelona, Spain. 7–12 July 2002. Abstract TuPeB4463.
Nadler J, Gathe J, Pollard R, Richmond G, Liao Q, Lancaster T, et al.: Twice-daily Amprenavir 1200mg vs Amprenavir 600mg/Ritonavir 100mg, in combination with at least 2 other antiretroviral drugs in HIV-1 infected subjects. BMC Infectious Disease 2003, 3:10.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
June 2000 to May 2002
Type
Not applicable
Phase
4
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
2002-14-05
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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