Unboosted Atazanavir as Initial ART Therapy in China

This study has been completed.
Sponsor:
Collaborator:
BMS company
Information provided by (Responsible Party):
NCAIDS, National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:
NCT01459575
First received: October 24, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted

October 24, 2011
October 24, 2011
July 2005
December 2005   (final data collection date for primary outcome measure)
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No Changes Posted
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Unboosted Atazanavir as Initial ART Therapy in China
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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 setting.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

ART-naïve patients, established HIV infection > 6 months with CD4 count of 100~350 cell/mm3

Antiretroviral Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2006
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01459575
ATV 2005
No
NCAIDS, National Center for AIDS/STD Control and Prevention, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
BMS company
Principal Investigator: Fujie Zhang, MD National Center for AIDS/STD control and prevention
National Center for AIDS/STD Control and Prevention, China CDC
October 2011

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