Phase IIB Pilot of Atazanavir + Raltegravir (SPARTAN)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: HIV

Treatments: Drug: Tenofovir/Emtricitabine; Drug: Raltegravir; Drug: Atazanavir; Drug: Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768989

AI424-376

Details and patient eligibility

About

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Human Immunodeficiency Virus (HIV)-1 positive status

• HIV ribonucleic acid (RNA) level >=5000 copies/mL

• Antiretroviral treatment-naive

• Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:

• <350 cells/mm^3

• Screening CD4 >=350 and <=500 cells/mm^3 ONLY if at least 1 of the following conditions apply:

  • Screening HIV RNA level >100,000 copies/mL, or
  • CD4 decline >50-100 cells/mm^3/year, or
  • Age >=55 years

• Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness

• Medically stable

Exclusion criteria

• Screening HIV genotype showing resistance to any component of the study regimen (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)
• Hepatitis B or hepatitis C coinfection
• History of or current cardiac disease
• Electrocardiogram findings:
• PR Interval >260 msec (severe 1st degree atrioventricular block)
• QRS Interval >120 msec

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

Atazanavir + Raltegravir

Experimental group

Description:

Atazanavir 300 mg twice daily + Raltegravir 400 mg twice daily

Treatment:

Drug: Atazanavir

Drug: Atazanavir

Drug: Raltegravir

Atazanavir + Ritonavir + Tenofovir /Emtricitabine

Active Comparator group

Description:

Atazanavir, 300 mg once daily, + Ritonavir, 100 mg once daily, + Tenofovir 300 mg/Emtricitabine, 200 mg once daily

Treatment:

Drug: Ritonavir

Drug: Atazanavir

Drug: Atazanavir

Drug: Tenofovir/Emtricitabine