Unboosted Atazanavir as Initial ART Therapy in China

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01459575

Enrollment

Unknown

Registered

2011-10-25

Start date

2005-07-31

Completion date

2006-12-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiretroviral Therapy

Keywords

Acquired Immunodeficiency Syndrome, antiretroviral therapy, China

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Countries

China

Outcome results