Telephone Support to Improve Adherence to Anti-HIV Medications
Stopped early · Phase 2
Conditions studied: HIV Infections
In brief
This study tested a system of nursing telephone support to determine if it improves adherence to antiretroviral therapy (ART) in at-risk, treatment-experienced people.
Key facts
- Study ID
- NCT00988442
- Run by
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- People needed
- 59
- Starts
- 2010-10-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2017-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an approved A5251 parent or coenrolling partner study ("ACTG parent study participant") or not enrolled in one of the ACTG parent studies, but receiving routine HIV patient care at an institution that was also an ACTG-funded site ("ACTG clinic patient participant").
- Virologic failure on combination antiretroviral therapy (ART), with an HIV-1 genotype conducted on or soon after the failure, within 16 weeks prior to entry. Availability of HIV-1 genotype results at entry.
- History of prior nonadherence to ART during the past year documented either by patient self-report or recorded in the patient's medical record
- Most recent HIV-1 RNA value of at least 200 copies/mL, obtained within 90 days prior to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA
- Initiating or restarting an ART regimen with 2 or more active ARV medications within 3 days after randomization. The regimen must have been selected for the participant prior to the time of randomization for A5251. An active ARV medication was defined as a medication to which the participant was expected to be susceptible based on HIV-1 resistance testing, as specified in the ACTG parent study, or determined by the participant's health care provider per standard of care.
You may not qualify if…
- No regular access to a phone. Candidates without phones may have elected to participate by calling the HIV nurse specialists using an 800 number, rather than being called by the HIV nurse specialist.
- Coenrollment in another adherence trial, unless approved by the A5251 study chair
- Current incarceration
- Any condition that, in the opinion of the site investigator, would have compromised the candidate's ability to participate in the study
Where it is running
- Alabama Therapeutics CRS — Birmingham, Alabama, United States
- Ucsd, Avrc Crs — San Diego, California, United States
- Northwestern University CRS (2701) — Chicago, Illinois, United States
- Rush University Medical Center ACTG — Chicago, Illinois, United States
- Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
- Bmc Actg Crs (104) — Boston, Massachusetts, United States
- Cooper Univ. Hosp. CRS (31476) — Camden, New Jersey, United States
- New Jersey Medical School-Adult Clinical Research Ctr. CRS — Newark, New Jersey, United States
- Cornell CRS — New York, New York, United States
- HIV Prevention & Treatment CRS — New York, New York, United States
- Unc Aids Crs — Chapel Hill, North Carolina, United States
- Duke University Medical Center Adult CRS — Durham, North Carolina, United States
- MetroHealth CRS — Cleveland, Ohio, United States
- Hospital of the University of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
- Vanderbilt Therapeutics CRS — Nashville, Tennessee, United States
- 31443 Trinity Health and Wellness Center CRS — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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