Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients (SPARTAN)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: HIV, Combination Therapy

Treatments: Drug: Ritonavir (heat-stable); Drug: Tenofovir/Emtricitabine; Drug: Raltegravir; Drug: Atazanavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332227

2009-017032-41 (EudraCT Number)

AI424-402

Details and patient eligibility

About

The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

Full description

Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening
• Virologic suppression (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to screening
• Virologic suppression (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
• Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent

Key Exclusion Criteria

• History of switch in highly active antiretroviral therapy due to virologic failure
• History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
• History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
• Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
• Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Atazanavir/Ritonavir + Raltegravir

Experimental group

Description:

Atazanavir + Ritonavir (heat-stable) + Raltegravir

Treatment:

Drug: Atazanavir

Drug: Raltegravir

Drug: Ritonavir (heat-stable)

Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Other group

Description:

Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine

Treatment:

Drug: Atazanavir

Drug: Tenofovir/Emtricitabine

Drug: Ritonavir (heat-stable)