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.

Community Research Initiative of New England

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: atazanavir/raltegravir; Drug: atazanavir/tenofovir/emtricitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00931801

09-102

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 3 patient groups

Intervention Arm No.1

Experimental group

Treatment:

Drug: atazanavir/raltegravir

Drug: atazanavir/raltegravir

Intervention Arm No.2

Experimental group

Treatment:

Drug: atazanavir/raltegravir

Drug: atazanavir/raltegravir

Control Arm

Active Comparator group

Description:

Continue baseline regimen

Treatment:

Drug: atazanavir/tenofovir/emtricitabine