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.

NCT ID: NCT00931801

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-03-31

Brief Summary

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm No.1

Group Type: EXPERIMENTAL

atazanavir/raltegravir

Intervention Type: DRUG

Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily

Intervention Arm No.2

Group Type: EXPERIMENTAL

atazanavir/raltegravir

Intervention Type: DRUG

Atazanavir 300mg twice daily plus raltegravir 400mg twice daily

Control Arm

Continue baseline regimen

Group Type: ACTIVE_COMPARATOR

atazanavir/tenofovir/emtricitabine

Intervention Type: DRUG

Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine

Interventions

atazanavir/raltegravir

Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily

Intervention Type: DRUG

atazanavir/raltegravir

Atazanavir 300mg twice daily plus raltegravir 400mg twice daily

Intervention Type: DRUG

atazanavir/tenofovir/emtricitabine

Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine

Intervention Type: DRUG

Other Intervention Names

Truvada

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Community Research Initiative of New England

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Calvin J Cohen, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Community Research Initiative

Locations

Spectrum Medical Group

Phoenix, Arizona, United States

AIDS Healthcare Foundation

Los Angeles, California, United States

Denver Public Health

Denver, Colorado, United States

Whitman-Walker Clinic

Washington D.C., District of Columbia, United States

Orlando Immunology Center

Orlando, Florida, United States

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, United States

Christi Research

Wichita, Kansas, United States

Community Research Initiative of New England - Boston

Boston, Massachusetts, United States

David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group

Dallas, Texas, United States

Countries

United States

Other Identifiers

09-102

Identifier Type: -

Identifier Source: org_study_id