Unboosted Atazanavir as Initial ART Therapy in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Antiretroviral Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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NCAIDS

National Center for AIDS/STD Control and Prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fujie Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

National Center for AIDS/STD control and prevention

Locations

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Yan Zhao

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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ATV 2005

Identifier Type: -

Identifier Source: org_study_id