Unboosted Atazanavir as Initial ART Therapy in China

National Center for AIDS/STD Control and Prevention, China CDC

Status: Completed

Conditions: Antiretroviral Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT01459575

ATV 2005

Details and patient eligibility

About

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.