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
  Purpose

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.


Condition
Antiretroviral Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:

Study Start Date: July 2005
Study Completion Date: December 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459575

Locations
China
Yan Zhao
Beijing, China, 100050
Sponsors and Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
BMS company
Investigators
Principal Investigator: Fujie Zhang, MD National Center for AIDS/STD control and prevention
  More Information

No publications provided

Responsible Party: NCAIDS, National Center for AIDS/STD Control and Prevention, National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier: NCT01459575     History of Changes
Other Study ID Numbers: ATV 2005
Study First Received: October 24, 2011
Last Updated: October 24, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
Acquired Immunodeficiency Syndrome
antiretroviral therapy
China

ClinicalTrials.gov processed this record on July 26, 2014