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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. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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.

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

NCT00931801•Community Research Initiative of New England

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (9)

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

Key Dates

Start Date

December 1, 2009

Primary Completion Date

February 1, 2012

Completion Date

March 1, 2012

Last Updated

July 21, 2017

Enrollment

ACTUAL participants

Conditions

HIV

Interventions

atazanavir/raltegravir

DRUG

atazanavir/raltegravir

DRUG

atazanavir/tenofovir/emtricitabine

DRUG

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITINGPHASE2

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.

Inclusion Criteria

Exclusion Criteria

Thinking and Memory Problems in People With HIV

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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