Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00411957 |
Recruitment Status
:
Completed
First Posted
: December 15, 2006
Last Update Posted
: June 7, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Pharmacokinetics of Atazanavir / Ritonavir 200/100 OD Versus 300/100 mg OD in Combination With 2 NRTIs in HIV Pre-treated Patients |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
ATV/r 300/100 mg
|
Drug: Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
|
Active Comparator: 2
ATV/r 200/100 mg OD
|
Drug: Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
|
- the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success [ Time Frame: 1 year ]
- The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD [ Time Frame: 4 weeks ]
- short term safety, tolerability and efficacy data in these PK participating patients [ Time Frame: 4 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent
- Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs
- HIV RNA < 50 copies/ml
Exclusion Criteria:
- Inability to understand the nature and extent of the study and the procedures required.
- ALT/ AST more than 5x upper limit
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of atazanavir, and ritonavir
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- Active drug abuse or heavy alcoholic drinking
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- Active drug abuse or heavy alcoholic drinking

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): NCT00411957
Thailand | |
HIV-NAT, Thai Red Cross AIDS Research Center | |
Bangkok, Thailand, 10300 |
Principal Investigator: | Kiat Ruxrungtham, MD | HIV-NAT Thai Red Cross AIDS Research Center |
Additional Information:
Publications of Results:
Responsible Party: | Kiat Ruxrungtham, HIV-NAT |
ClinicalTrials.gov Identifier: | NCT00411957 History of Changes |
Other Study ID Numbers: |
HIV-NAT 073 |
First Posted: | December 15, 2006 Key Record Dates |
Last Update Posted: | June 7, 2010 |
Last Verified: | June 2010 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
atazanavir/ritonavir pharmacokinetic of ATV/r200/100 OD+2NRTIs |
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 Ritonavir 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 Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |