Unboosted Atazanavir as Initial ART Therapy in China

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.

Study Overview

• Status: Completed
• Conditions: Antiretroviral Therapy

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
    • Yan Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Collaborators: BMS company
• Investigators: Principal Investigator: Fujie Zhang, MD, National Center for AIDS/STD control and prevention

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Estimate): October 25, 2011
• Last Update Submitted That Met QC Criteria: October 24, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: China; Acquired Immunodeficiency Syndrome; antiretroviral therapy
• Other Study ID Numbers: ATV 2005