BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated. (BATAR)

A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine

The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: atazanavir/raltegravir; Drug: atazanavir/raltegravir; Drug: atazanavir/tenofovir/emtricitabine

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Spectrum Medical Group
  • California
    • Los Angeles, California, United States, 90028
      • AIDS Healthcare Foundation
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver public Health
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20009
      • Whitman-Walker Clinic
  • Florida
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Vero Beach, Florida, United States, 32960
      • Treasure Coast Infectious Disease Consultants
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Christi Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Community Research Initiative of New England - Boston
  • Texas
    • Dallas, Texas, United States, 75804
      • David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV-1 infection
• Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
• No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
• Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
• CD4 count>200
• No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
• Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
• Ability and willingness to provide written informed consent and comply with protocol requirements

Exclusion Criteria:

• Prior exposure to raltegravir or elvitegravir
• Women who are pregnant, breast-feeding, or with a positive pregnancy test
• Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
• Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
• Life expectancy less than 6 months
• Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
• Treatment with proton-pump inhibitor or H2-receptor antagonist
• ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
• Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
• Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
• Prisoners or subjects who are involuntarily incarcerated
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm No.1	Drug: atazanavir/raltegravir; Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily; Drug: atazanavir/raltegravir; Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Experimental: Intervention Arm No.2	Drug: atazanavir/raltegravir; Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily; Drug: atazanavir/raltegravir; Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Active Comparator: Control Arm; Continue baseline regimen	Drug: atazanavir/tenofovir/emtricitabine; Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine; Other Names: Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Virologic Suppression	To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Difference in CD4 From Baseline to Week 48	Change in mean CD4 from Baseline to Week 48.	Baseline and Week 48
The Change in Adherence to Study Treatment Arm From Baseline to Week 48	Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.	Baseline and Week 48
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment	Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.	baseline and 48 weeks

Collaborators and Investigators

• Sponsor: Community Research Initiative of New England
• Collaborators: Bristol-Myers Squibb; Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Calvin J Cohen, MD, MSc, Community Research Initiative

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 30, 2009
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (Estimate): July 2, 2009

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Tenofovir; AIDS; Atazanavir; Raltegravir; protease inhibitors
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Emtricitabine; Raltegravir Potassium; Atazanavir Sulfate
• Other Study ID Numbers: 09-102