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OpenTrials
Completed

NCT Number: NCT00357188

Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects

The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Protease Inhibitor RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Hamilton, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18-30
  • Men and women who are not of childbearing potential, ages 18-50 years, inclusive

Exclusion criteria

  • History of seizures or other central nervous system disorders (including migraine headaches)
  • history of diagnosed mental illness or suicidal tendencies
  • positive screening for Hep B surface antigen
  • Hep C antibody
  • HIV-1, -2

Treatment and study plan

Atazanavir Sulphate + Ritonavir

Drug

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.

Other names: Reyataz

Atazanavir Sulphate + Ritonavir + Efavirenz

Drug

Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.

Other names: Reyataz, Sustiva

Primary outcomes

  1. To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects

Secondary outcomes

  1. To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening

  2. To assess the PK of RTV when dosed as ATV 400 mg with RTV 100 mg and with EFV 600 mg in the evening relative to ATV 300 mg with RTV 100 mg alone

  3. To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Open-Label, Multiple Dose Study to Determine the Relative Bioavailability of Atazanavir (ATV) 400 mg Administered With Ritonavir (RTV) and Efavirenz (EFV) Compared to Atazanavir 300 mg Administered With Ritonavir Alone in Healthy Subjects

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 27, 2006
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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