Atazanavir Twice Daily
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ClinicalTrials.gov Identifier: NCT00357721 |
Recruitment Status
:
Completed
First Posted
: July 27, 2006
Last Update Posted
: April 6, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Protease Inhibitor | Drug: Atazanavir Sulphate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A1 |
Drug: Atazanavir Sulphate
Capsules, Oral, 200 mg, twice daily, 7 days.
Other Name: Reyataz
|
Active Comparator: A2 |
Drug: Atazanavir Sulphate
Capsules, Oral, 300 mg, twice daily, 8 days.
Other Name: Reyataz
|
Active Comparator: A3 |
Drug: Atazanavir Sulphate
Capsules, Oral, 400 mg, twice daily, 9 days.
Other Name: Reyataz
|
- Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
- Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
- Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
- Assess the effect of atazanavir BID on metabolic parameters
- Assess the safety and tolerability of atazanavir when administered BID

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357721
United States, New Jersey | |
Local Institution | |
Hamilton, New Jersey, United States |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00357721 History of Changes |
Other Study ID Numbers: |
AI424-286 |
First Posted: | July 27, 2006 Key Record Dates |
Last Update Posted: | April 6, 2011 |
Last Verified: | April 2011 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |