Antiretroviral TherapyNCT01459575
Unboosted Atazanavir as Initial ART Therapy in China
An observational study of Antiretroviral Therapy, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Antiretroviral Therapy
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Jul 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ART-naïve patients, established HIV infection > 6 months with CD4 count of 100~350 cell/mm3
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startJul 2005
- Primary completionDec 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiretroviral TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- Collaborators
- BMS company
- Responsible party
- Principal investigator, NCAIDS, National Center for AIDS/STD Control and Prevention, China CDC
- Investigators
- Fujie Zhang, MD, Principal investigator, National Center for AIDS/STD control and prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459575
- Sponsor's protocol ID
- ATV 2005
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unboosted Atazanavir as Initial ART Therapy in China
- ClinicalTrials.gov ID
- NCT01459575
- Acronym / sponsor ID
- ATV 2005
- Conditions
- Antiretroviral Therapy
- Keywords
- Acquired Immunodeficiency Syndrome, antiretroviral therapy, China
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- Collaborators
- BMS company
- Study start
- Jul 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ART-naïve patients, established HIV infection > 6 months with CD4 count of 100~350 cell/mm3
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fujie Zhang, MD principal investigator
National Center for AIDS/STD control and prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiretroviral Therapy, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2011.