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OpenTrials
Completed

NCT Number: NCT00357721

Atazanavir Twice Daily

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

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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–45 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

  • Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2

Treatment and study plan

Atazanavir Sulphate

Drug

Capsules, Oral, 200 mg, twice daily, 7 days.

Other names: Reyataz

Primary outcomes

  1. Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.

Secondary outcomes

  1. Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID

  2. Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform

  3. Assess the effect of atazanavir BID on metabolic parameters

  4. Assess the safety and tolerability of atazanavir when administered BID

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jul 27, 2006
Registry last updated
Apr 6, 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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