This study was designed to test the efficacy, safety, tolerability and durability of the
antiviral response between atazanavir (ATV) + ritonavir (RTV) + abacavir/lamivudine(ABC/3TC)
each administered once daily (QD) for 36 weeks followed by randomization to either a
simplification regimen of ATV or continuation of ATV+RTV for an additional 48 weeks, each in
combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative
subjects.
Inclusion criteria:
- Subject is ≥ 18 years of age and has documented evidence of HIV-1 infection. (A
female is eligible to enter and participate in this study if she is of: non
child-bearing potential, child bearing potential with a negative pregnancy test and
agrees to approved contraception methods, or agreement for complete abstinence.)
- Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any
NRTI and no prior therapy with either a PI or NNRTI).
- Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL by Roche COBAS AMPLICOR™ (Version 1. 5)
method at screening (if no other documentation of HIV infection is available, a
positive result here may serve as documentation of HIV infection for this study).
- Subject is willing and able to understand and provide written informed consent prior
to participation in this study.
Exclusion criteria:
- Subject is HLA-B*5701 positive.
- Subject testing positive for Hepatitis B or both Hepatitis B and Hepatitis C at
screening (+ HbsAg)
- Genotyping results performed at the screening indicate that the subject has any of the
following mutations at the reverse transcriptase (RT) enzyme: K65R, L74V, or Y115F,
or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or
E) that include changes at either L210 or T215, or ≥ 3 of the following protease
mutations associated with atazanavir resistance: D30, V32, M36, M46, I47, G48, I50,
I54, A71, G73, V77, V82, I84, N88, and L90.
- Women who are pregnant or breastfeeding.
- Subject has an active or acute CDC Clinical Category C event at screening. Treatment
for the acute event must have been completed at least 30 days prior to screening.
- Subject is, in the opinion of the investigator, unable to complete the 84-week dosing
period and protocol evaluations and assessments.
- Subject has ongoing clinically relevant pancreatitis or clinically relevant hepatitis
at screening.
- Presence of a newly diagnosed HIV-related opportunistic infection or any medical
condition requiring acute therapy at the time of enrollment.
- Subject suffers from a serious medical condition, such as diabetes, congestive heart
failure, cardiomyopathy or other cardiac dysfunction (including known, clinically
significant cardiac conduction system disease, severe first degree atrioventricular
block [PR interval > 0. 26 seconds], second or third-degree atrioventricular block),
which in the opinion of the investigator would compromise the safety of the subject.
- Subject has pre-existing mental, physical, or substance abuse disorder, which in the
opinion of the investigator would interfere with the subject's ability to comply with
the dosing schedule and protocol evaluations and assessments.
- Subject has a history of inflammatory bowel disease or malignancy, intestinal
ischemia, malabsorption, or other gastrointestinal dysfunction, which may interfere
with drug absorption or render the subject unable to take oral medication.
- Subject requires treatment with foscarnet, hydroxyurea or other agents with documented
activity against HIV-1 in vitro within 28 days of study administration.
- Subject requires treatment with immunomodulating agents (such as systemic
corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to
screening, or subject had received an HIV-1 immunotherapeutic vaccine within 90 days
prior to screening. Subjects using inhaled corticosteroids are eligible for
enrollment.
- Creatinine clearance <50 mL/min via the Cockroft-Gault method [Cockroft, 1976].
- Active alcohol or substance use sufficient, in the investigator's opinion, to prevent
adequate compliance with study therapy or to increase the risk of developing
pancreatitis or chemical hepatitis.
- Hypersensitivity to any component of the study drugs.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper
limit of normal (ULN).
- Total bilirubin > 1. 5 times the upper limit of normal (ULN).
- Subject has any acute laboratory abnormality at screening, which, in the opinion of
the investigator, would preclude the subject's participation in the study of an
investigational compound. Any grade 4 laboratory abnormality would exclude a subject
from study participation.
- Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents
within 28 days prior to screening, or has an anticipated need for these agents within
the study period.
- Enrolled in one or more investigational drug protocols, which may have impacted HIV-1
RNA suppression.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e. g., infectious disease) illness must
not be enrolled into this study.
- Subjects requiring concomitant administration of proton pump inhibitors.
- Subjects who require treatment with the prohibited medications within 28 days of
commencement of investigational product, or an anticipated need during the study.
GSK Clinical Trials Call Center, Ponce 00717, Puerto Rico
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