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
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 April 23, 2014