Status:
COMPLETED
Unboosted Atazanavir as Initial ART Therapy in China
Lead Sponsor:
National Center for AIDS/STD Control and Prevention, China CDC
Collaborating Sponsors:
BMS company
Conditions:
Antiretroviral Therapy
Eligibility:
All Genders
16+ years
Brief Summary
This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese resource-limited set...
Eligibility Criteria
Inclusion
- Signed written informed consent
- The subject should have established HIV infection more than 6 month.
- Qualifying plasma HIV RNA ≥ 2,000 c/mL and a CD4 cell count within 100 - 350 cells/mm3
- ≥16 years of age
- Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
Exclusion
- Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
- History of hemophilia
- Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are \< 3 times the upper limit of normal.
- Presence of cardiomyopathy.
- A history of arrhythmia or clinical symptoms potentially related to heart block or second / third degree heart block.
- Inability to tolerate oral medication
- Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01459575
Start Date
July 1 2005
End Date
December 1 2006
Last Update
October 25 2011
Active Locations (1)
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1
Yan Zhao
Beijing, China, 100050