Unboosted Atazanavir as Initial ART Therapy in China

NCT01459575 | Completed

• 1 other identifier: ATV 2005
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Antiretroviral Therapy

Keywords

Acquired Immunodeficiency Syndrome; antiretroviral therapy; China

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for AIDS/STD Control and Prevention, China CDC: lead
• BMS company: collaborator

Study Sites (1)

Yan Zhao

Beijing, 100050, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Fujie Zhang, MD

  National Center for AIDS/STD control and prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Center for AIDS/STD Control and Prevention

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 25, 2011
• Study Start: July 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2006
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

CN (1)