HIV InfectionsNCT01006005
Adherence-Suppression-Resistance Relationships for Atripla Compared to Historical Antiretroviral Regimens
An observational study of HIV Infections and Adherence, run by University of California, San Francisco.
Trial summary
The study is recruiting 50 patients initiating or switching to Atripla and comparing them to 250 individuals previously followed in a prospective study of HIV+ low income individuals recruited from homeless shelters, single room occupancy hotels and free meal food lines as part of the UCSF Reach Study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Adherence
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jun 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected, marginally housed
Who may be able to join
- 18+ years old;
- HIV+;
- Initiating Atripla within 6-months of recruitment;
- Lives in the Tenderloin, South of Market, or Mission District San Francisco;
- Capable of providing informed consent; and
- Willing to complete all study procedures.
Who cannot join
- Intoxication, cognitive dysfunction or psychosis will preclude potential subjects from informed consent.
About this study
The study is recruiting 50 patients initiating or switching to Atripla and comparing them to 250 individuals previously followed in a prospective study of HIV+ low income individuals recruited from homeless shelters, single room occupancy hotels and free meal food lines as part of the UCSF Reach Study. Adherence will be measured through monthly unannounced pill counts and electronic medication monitors.
- Conditions
- HIV Infections, Adherence
- Keywords
- HIV, Treatment experienced
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006005
- Sponsor's protocol ID
- IN-US-177-0106
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2009
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence-Suppression-Resistance Relationships for Atripla Compared to Historical Antiretroviral Regimens
- ClinicalTrials.gov ID
- NCT01006005
- Acronym / sponsor ID
- IN-US-177-0106
- Conditions
- HIV Infections, Adherence
- Keywords
- HIV, Treatment experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Nov 2009 (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.
The study is recruiting 50 patients initiating or switching to Atripla and comparing them to 250 individuals previously followed in a prospective study of HIV+ low income individuals recruited from homeless shelters, single room occupancy hotels and free meal food lines as part of the UCSF Reach Study. Adherence will be measured through monthly unannounced pill counts and electronic medication monitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected, marginally housed
Key inclusion criteria (6 listed)
- 18+ years old;
- HIV+;
- Initiating Atripla within 6-months of recruitment;
- Lives in the Tenderloin, South of Market, or Mission District San Francisco;
- Capable of providing informed consent; and
Key exclusion criteria (1 listed)
- Intoxication, cognitive dysfunction or psychosis will preclude potential subjects from informed consent.
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 8 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Adherence, run by University of California, San Francisco.
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 1 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 8 Nov 2023.