RECRUITING

Observational PIC Destination Cohort

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Conditions

HIV-1-infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to see if people who control HIV without antiretroviral therapy (ART) after receiving an intervention can remain off ART safely. The information collected in this study is also being used to try to understand how people control HIV without ART after receiving an intervention.

Official Title

An Observational Post-Intervention Control Destination Cohort

Quick Facts

Study Start:2024-03-19
Study Completion:2029-09-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05985642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently or previously enrolled in a qualifying ACTG or non- ACTG parent study of curative or suppressive HIV therapy that included an ATI.
  2. * If feasible, participants should not remain co-enrolled in their respective parent study after entering A5385.
  3. * Achieved at least 24 weeks of HIV virus suppression (as defined by the parent study) following ATI initiation, remains off ART with \<4 consecutive weeks of HIV-1 RNA \>1000 copies/mL, CD4+ T-cell count \> 350 cells/mm3 and not experiencing symptoms of acute retroviral syndrome.
  4. * CD4+ T cell count \>350 cells/mm3 obtained within 28 days prior to study entry at any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that is IQA certified.
  5. * Willingness to continue ATI for up to 96 weeks or until ART restart criteria are met, and to remain in follow up for 48 weeks after ART restart.
  6. * For participants who are able to become pregnant, negative serum or urine pregnancy test within 24 hours prior to study entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point of care (POC)/CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
  7. * Participants who are able to become pregnant and are engaging in sexual activity that could lead to pregnancy must agree to use one highly effective method of contraception throughout the course of the study from the list below.
  8. * Barrier method
  9. * Contraceptive subdermal implant
  10. * Intrauterine device or intrauterine system
  11. * Combined estrogen and progestogen oral contraceptive
  12. * Injectable progestogen
  13. * Contraceptive vaginal ring
  14. * Percutaneous contraceptive patches
  15. * Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant.
  16. * Willingness to use barrier protection (male or female) during sexual activity with all partners not on effective pre-exposure prophylaxis (PrEP) throughout Step 1 ATI and until viral re-suppression in Step 2.
  17. * Ability and willingness of participant to provide informed consent.
  1. * Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during continued ATI.
  2. * Medical or psychiatric condition (including pregnancy or breastfeeding) that, in the opinion of the site investigator, would place the participant at higher risk of morbidity or would interfere with adherence to study requirements.

Contacts and Locations

Study Contact

ACTG ClinicalTrials.gov Coordinator
CONTACT
(301)628-3348
ACTGCT.gov@dlhcorp.com

Principal Investigator

Katharine Bar, MD
STUDY_CHAIR
Penn Therapeutics Clinical Research Site

Study Locations (Sites)

University of California, San Francisco HIV/AIDS CRS (801)
San Francisco, California, 94110
United States
Washington University Therapeutics (WT) CRS (2101)
Saint Louis, Missouri, 63110
United States
Weill Cornell Upton CRS (7803)
New York, New York, 10065
United States
Case CRS (2501)
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  • Katharine Bar, MD, STUDY_CHAIR, Penn Therapeutics Clinical Research Site

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-19
Study Completion Date2029-09-03

Study Record Updates

Study Start Date2024-03-19
Study Completion Date2029-09-03

Terms related to this study

Additional Relevant MeSH Terms

  • HIV-1-infection