Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naïve HIV-1 Infected Adult Subjects.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Subject is =18 years of age
2. Subject is antiretroviral-naïve (defined as having =14 days of prior therapy with any antiretroviral agent).
3. Subject has plasma HIV-1 RNA =1,000 copies/mL at screening.
4. Subject is willing and able to understand and provide written informed consent prior to participation in this study.
5. A female is eligible to enter and participate in the study if she is of:
a. Non-childbearing potential (i.e., physiologically incapable of becoming
pregnant, including any female who is post-menopausal); or,
b. Child-bearing potential, has a negative pregnancy test (serum ß-HCG) at screen
and agrees to one of the following methods of contraception (any contraception
method must be used consistently and correctly, i.e., in accordance with both the
approved product label and the instructions of a physician):
- Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, throughout the study, and for at least 2 weeks after discontinuation of all study medications
- Double barrier method (male condom/spermicide, male condom/diaphragm,
diaphragm/spermicide). Hormonal contraception will not be permitted in this study
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year.
- Sterilization (female subject or male partner of female subject).
6. Prior to randomization, subjects entering Stage 2 must have been screened and be negative for the HLA-B*5701 allele. Test may be performed by local laboratory and results must be available for source document verification according to local
practices.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject is in the initial acute phase of a CDC Clinical Category C infection at
Baseline. Subjects may be enrolled provided they are receiving treatment for such
infections and are clinically improving at the Baseline visit.
2. Subject is enrolled in one or more investigational drug protocols, which may impact
HIV RNA suppression.
3. Subject is either pregnant or breastfeeding.
4. Subject has an estimated creatinine clearance < 50 mL/min via the Cockcroft-Gault
method [Cockcroft, 1976]. This test may be repeated once within the 45-day
screening window.
5. Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) or
hepatic impairment as determined by Child-Pugh Score = 5.
6. Subject is receiving, or has received within 90 days prior to screen, any lipid
lowering agent, including drugs from the following classes: HMG-CoA reductase
inhibitors (statins), niacin, fibrates, bile acid sequestrants, and/or fish oil
supplements. Subjects anticipated to require initiation of therapy with these agents
within 12 weeks of Baseline are not eligible to participate.
7. Subject has evidence of genotypic (as defined by the current ANRS AC-11
algorithm) resistance at screening or prior documented evidence of genotypic and/or
phenotypic (above threshold for reduced susceptibility) resistance to
amprenavir/ritonavir, abacavir or lamivudine.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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