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To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir boosted with ritonavir in treatment naive patients.
Full description
To determine the safety and efficacy (viral load suppression and cluster of differentiation 4 [CD4] changes) of a simple, once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with the protease inhibitor atazanavir (ATV) boosted with ritonavir (ATV/r).
To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir.
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
To evaluate steady-state plasma pharmacokinetics (PK) of Truvada and atazanavir in study subjects receiving Truvada and boosted atazanavir.
Enrollment
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Inclusion criteria
Exclusion criteria
Prior antiretroviral treatment.
Screening ALT greater than 5 x the upper limit of the normal range (ULN).
Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver transaminases (ALT) are less than 5 x ULN.
A new AIDS defining condition diagnosed (with the exception of CD4 criteria) within 30 days of baseline.
Previous therapy with agents with systemic myelosuppressive, pancreatoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
Presence of cardiomyopathy.
Heart rate less than 40 bpm.
Clinical symptoms potentially related to heart block (syncope, palpitations, unexplained dizziness)
Known conduction disease.
Third degree heart block.
Clinically significant laboratory values that would preclude prescribing antiretroviral therapy, in the opinion of the investigator.
Receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period):
Drugs that are contraindicated with atazanavir and/or ritonavir including:
Pregnant or lactating subjects.
Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
Current alcohol or substance abuse judged by the investigator to potentially interfere with subject adherence.
Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study.
Active, serious infections (other than HIV 1 infection) requiring parenteral antimicrobial therapy within 15 days prior to screening.
Prior history of significant renal or bone disease.
Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g., infectious disease) illness.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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