Unboosted Atazanavir as Initial ART Therapy in China

Antiretroviral Therapy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459575
• Other study ID #: ATV 2005
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: October 24, 2011
• Start date: July 2005
• Est. completion date: December 2006

Study information

• Verified date: October 2011
• Source: National Center for AIDS/STD Control and Prevention, China CDC
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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 setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antiretroviral Therapy

Locations

Country	Name	City	State
China	Yan Zhao	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
National Center for AIDS/STD Control and Prevention, China CDC	BMS company

Country where clinical trial is conducted

China,