Clinical trial NCT00931801: 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.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: AIDS
HIV
Atazanavir
Raltegravir
Tenofovir
protease inhibitors
Lead sponsor: Community Research Initiative of New England
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Merck Sharp & Dohme LLC
First posted: 2009-07-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maintenance of Virologic Suppression
timeFrame: 48 weeks
Secondary outcomes:
measure: The Difference in CD4 From Baseline to Week 48
timeFrame: Baseline and Week 48
measure: The Change in Adherence to Study Treatment Arm From Baseline to Week 48
timeFrame: Baseline and Week 48
measure: Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
timeFrame: baseline and 48 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Spectrum Medical Group
state: Arizona
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Denver
country: United States
facility: Denver Public Health
state: Colorado
city: Washington, D.C.
country: United States
facility: Whitman-Walker Clinic
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Wichita
country: United States
facility: Christi Research
state: Kansas
city: Boston
country: United States
facility: Community Research Initiative of New England - Boston
state: Massachusetts
city: Dallas
country: United States
facility: David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group
state: Texas
Study officials:
affiliation: Community Research Initiative
name: Calvin J Cohen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: