This study will examine the safety of giving antiviral therapy for HIV infection in a
once-daily dosing schedule, and assess how well patients tolerate this regimen. A once a day
dosing schedule may be easier for some people to follow than one that requires taking
medicine 2 or 3 times a day. The ease of treatment is important, because not following the
prescribed dosing regimen may make therapy less effective or ineffective.
HIV-infected patients 18 years and older who have never been treated for their infection may
be eligible for this study. Candidates will be screened with a history and physical
examination, including blood tests. Participants will take the following medications once a
day: 1200 mg of amprenavir (8 capsules); 300 mg of ritonavir (3 capsules); 600 mg of abacavir
(2 pills); and 300 mg of lamivudine (2 pills). Patients will have routine blood tests and be
seen by a nurse or doctor, or both, at follow-up visits at weeks 2, 4, 8, 12, and 16; then
every 8 weeks until week 48; and then every 3 months for up to 3 years. At week 2, a special
blood test will be done over the course of a day to measure blood drug levels. For this test,
blood samples will be drawn 8 times over a 24-hour period. A heparin lock (a device that
allows the needle to remain in the vein) will be used to avoid multiple needle sticks.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)