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.

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00931801
First received: June 30, 2009
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
HIV
Drug: atazanavir/raltegravir
Drug: atazanavir/tenofovir/emtricitabine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Community Research Initiative of New England:

Primary Outcome Measures:
  • Maintenance of Virologic Suppression [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The Difference in CD4 From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Change in mean CD4 from Baseline to Week 48.

  • The Change in Adherence to Study Treatment Arm From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    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.

  • Change in Quality of Life From Baseline to 48 Weeks of Study Treatment [ Time Frame: baseline and 48 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: December 2009
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Arm No.1 Drug: atazanavir/raltegravir
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Experimental: Intervention Arm No.2 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 Name: Truvada

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931801

Locations
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
AIDS Healthcare Foundation
Los Angeles, California, United States, 90028
United States, Colorado
Denver Public Health
Denver, Colorado, United States, 80204
United States, District of Columbia
Whitman-Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Orlando Immunology Center
Orlando, Florida, United States, 32803
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Kansas
Christi Research
Wichita, Kansas, United States, 67214
United States, Massachusetts
Community Research Initiative of New England - Boston
Boston, Massachusetts, United States, 02215
United States, Texas
David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group
Dallas, Texas, United States, 75804
Sponsors and Collaborators
Community Research Initiative of New England
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Calvin J Cohen, MD, MSc Community Research Initiative
  More Information

No publications provided

Responsible Party: Cal Cohen, Director of Research, Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00931801     History of Changes
Other Study ID Numbers: 09-102
Study First Received: June 30, 2009
Results First Received: February 5, 2013
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Community Research Initiative of New England:
AIDS
HIV
Atazanavir
Raltegravir
Tenofovir
protease inhibitors

Additional relevant MeSH terms:
Atazanavir
Emtricitabine
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014