Boosted Atazanavir and Truvada Given Once-Daily (BATON Study): A Phase 4 Study of Safety, Efficacy & Adherence in HIV Infected, Antiretroviral Naïve Subjects Treated With a Simple Once-Daily Regimen
Overview
- Phase
- Phase 4
- Intervention
- Truvada
- Conditions
- HIV Infections
- Sponsor
- Gilead Sciences
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Determine the safety/efficacy (viral load suppression and CD4 changes) of a once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult (greater than or equal to 18 years) male or non-pregnant female HIV 1- infected subjects regardless of race or ethnicity.
- •Antiretroviral treatment-naïve.
- •Plasma HIV 1 RNA greater than 1000 copies/mL (Roche Amplicor HIV 1 Monitor Test Version 1.5 Ultrasensitive method, with a reflex to Standard for results greater than 75,000 and dilution for results greater than 750,000). There are no CD4 criteria for study inclusion.
- •Adequate renal function defined as a calculated creatinine clearance (CLCr) greater than or equal to 50 mL/min according to the Cockcroft-Gault formula:
- •Male: (140 - age in years) x (wt in kg) divided by 72 x (serum creatinine in mg/dL) = CLCr (mL/min.
- •Female: (140 - age in years) x (wt in kg) divided by 72 x (serum creatinine in mg/dL) x 0.85 = CLCr (mL/min).
- •Negative serum pregnancy test (females of childbearing potential only).
- •Males and females (of childbearing potential, i.e. less than 2 years post-menopausal) must agree to avoid pregnancy by sexual abstinence, or utilization of a highly effective method of birth control throughout the study period and for 30 days following discontinuation of study drug.
- •Life expectancy greater than or equal to 1 year.
- •Subjects should be available for follow up for a period of at least 48 weeks.
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.
Arms & Interventions
Truvada + Ritonavir-boosted Atazanavir
All participants received Truvada plus ritonavir-boosted atazanavir
Intervention: Truvada
Truvada + Ritonavir-boosted Atazanavir
All participants received Truvada plus ritonavir-boosted atazanavir
Intervention: Atazanavir
Truvada + Ritonavir-boosted Atazanavir
All participants received Truvada plus ritonavir-boosted atazanavir
Intervention: Ritonavir
Outcomes
Primary Outcomes
Determine the safety/efficacy (viral load suppression and CD4 changes) of a once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada.
Time Frame: Baseline to Week 48
Secondary Outcomes
- 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.(Baseline to Week 48)
- To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.(Baseline to Week 48)
- To evaluate steady-state plasma PK of Truvada & atazanavir in study subjects receiving Truvada and boosted atazanavir.(Baseline to Week 48)