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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.

Information source: Community Research Initiative of New England
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: atazanavir/raltegravir (Drug); atazanavir/raltegravir (Drug); atazanavir/tenofovir/emtricitabine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Community Research Initiative of New England

Official(s) and/or principal investigator(s):
Calvin J Cohen, MD, MSc, Principal Investigator, Affiliation: Community Research Initiative

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maintenance of Virologic Suppression

Secondary outcome:

The Difference in CD4 From Baseline to Week 48

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Spectrum Medical Group, Phoenix, Arizona 85012, United States

AIDS Healthcare Foundation, Los Angeles, California 90028, United States

Denver Public Health, Denver, Colorado 80204, United States

Whitman-Walker Clinic, Washington, District of Columbia 20009, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

Treasure Coast Infectious Disease Consultants, Vero Beach, Florida 32960, United States

Christi Research, Wichita, Kansas 67214, United States

Community Research Initiative of New England - Boston, Boston, Massachusetts 02215, United States

David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group, Dallas, Texas 75804, United States

Additional Information

Starting date: December 2009
Last updated: March 14, 2013

Page last updated: August 23, 2015

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