Last updated: 11/07/2018 16:32:47
Randomized, Multicenter, Open-Label Trial to Evaluate the Reversibility of Dyslipidemia upon Substitution of Abacavir for a Protease Inhibitor in Virologically Controlled HIV (+) Subjects with Elevated Cholesterol.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Randomized, Multicenter, Open-Label Trial to Evaluate the Reversibility of Dyslipidemia upon Substitution of Abacavir for a Protease Inhibitor in Virologically Controlled HIV (+) Subjects with Elevated Cholesterol.
Trial description: Randomized, Multicenter, Open-Label Trial to Evaluate the Reversibility of Dyslipidemia upon Substitution of Abacavir for a Protease Inhibitor in Virologically Controlled HIV (+) Subjects with Elevated Cholesterol.
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:
Keiser P, Sension M, DeJesus E, Rodriguez A, Olliffe J, Williams V, Snidow j, Shachoy?Clark A, Fleming J, and Hernandez J. Simplification of protease inhibitor (PI)-based HAART regimens with abacavir (ABC) improves hyperlipidemia and maintains viral suppression in HIV-1 infected adults (ESS40003). Poster WePeC6151267 XIV International AIDS Conference 6-12 July 2002, Barcelona Spain
Philip H Keiser, Michael G Sension, Edwin DeJesus, Allan Rodriguez, Jeffrey F Olliffe, Vanessa C Williams, John H Wakeford, Jerry W Snidow, Anne D Shachoy-Clark, Julie W Fleming, Gary E Pakes, Jaime E Hernandez, and for the ESS40003 Study Team Substituting abacavir for hyperlipidemia-associated protease inhibitors in HAART regimens improves fasting lipid profiles, maintains virologic suppression, and simplifies treatment BMC Infect Dis. 2005; 5: 2. Published online 2005 January 12.
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
November 1999 to November 2001
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
2001-05-11
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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