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.

NCT00931801 | Completed Phase 4 Results DMC

• 1 other identifier: 09-102
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 9

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

Keywords

AIDS; HIV; Atazanavir; Raltegravir; Tenofovir; protease inhibitors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Difference in CD4 From Baseline to Week 48

  Baseline and Week 48

• The Change in Adherence to Study Treatment Arm From Baseline to Week 48

  Baseline and Week 48

• Change in Quality of Life From Baseline to 48 Weeks of Study Treatment

  baseline and 48 weeks

Study Arms (3)

Intervention Arm No.1

EXPERIMENTAL

Drug: atazanavir/raltegravir

Intervention Arm No.2

EXPERIMENTAL

Drug: atazanavir/raltegravir

Control Arm

ACTIVE COMPARATOR

Continue baseline regimen

Drug: atazanavir/tenofovir/emtricitabine

Interventions

atazanavir/raltegravir DRUG

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

Intervention Arm No.1

atazanavir/tenofovir/emtricitabine DRUG

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

Also known as: Truvada

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Community Research Initiative of New England: lead
• Bristol-Myers Squibb: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (9)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

AIDS Healthcare Foundation

Los Angeles, California, 90028, United States

Location

Denver Public Health

Denver, Colorado, 80204, United States

Location

Whitman-Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Treasure Coast Infectious Disease Consultants

Vero Beach, Florida, 32960, United States

Location

Christi Research

Wichita, Kansas, 67214, United States

Location

Community Research Initiative of New England - Boston

Boston, Massachusetts, 02215, United States

Location

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

Dallas, Texas, 75804, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Atazanavir Sulfate; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Pyrrolidinones; Pyrrolidines; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Calvin J. Cohen MD, MSc, Director of Research
• Organization: Community Research Initiative of New England

ccohen@crine.org

617-502-1700

Study Officials

• Calvin J Cohen, MD, MSc

  Community Research Initiative

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 2, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 21, 2017
• Results First Posted: March 11, 2013

Record last verified: 2017-07

Locations

US (9)