Status:
TERMINATED
Telephone Support to Improve Adherence to Anti-HIV Medications
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Antiretroviral therapy (ART) is only successful in treating HIV when people take all the medications prescribed to them when and how they are instructed. However, a third or more of patients on ART ar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00988442
Start Date
October 1 2010
End Date
February 1 2013
Last Update
July 17 2017
Active Locations (16)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
Ucsd, Avrc Crs
San Diego, California, United States, 92103
3
Northwestern University CRS (2701)
Chicago, Illinois, United States, 60611
4
Rush University Medical Center ACTG
Chicago, Illinois, United States, 60612