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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00357188
First received: July 26, 2006
Last updated: April 7, 2011
Last verified: June 2008
History of Changes

July 26, 2006
April 7, 2011
July 2006
September 2006   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00357188 on ClinicalTrials.gov Archive Site
  • To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening
  • 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
  • To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects
Same as current
Not Provided
Not Provided
 
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
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

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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV Infections
  • Protease Inhibitor
  • Drug: Atazanavir Sulphate + Ritonavir
    Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
    Other Name: Reyataz
  • Drug: Atazanavir Sulphate + Ritonavir + Efavirenz
    Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
    Other Name: Reyataz, Sustiva
  • Active Comparator: A
    Intervention: Drug: Atazanavir Sulphate + Ritonavir
  • Active Comparator: B
    Intervention: Drug: Atazanavir Sulphate + Ritonavir + Efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00357188
AI424-283
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP