RECRUITING

Observational PIC Destination Cohort

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.

Conditions

Study Overview

Study Details

Study overview

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.

An Observational Post-Intervention Control Destination Cohort

Observational PIC Destination Cohort

Condition
HIV-1-infection
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco HIV/AIDS CRS (801), San Francisco, California, United States, 94110

Saint Louis

Washington University Therapeutics (WT) CRS (2101), Saint Louis, Missouri, United States, 63110

New York

Weill Cornell Upton CRS (7803), New York, New York, United States, 10065

Cleveland

Case CRS (2501), Cleveland, Ohio, United States, 44106

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Currently or previously enrolled in a qualifying ACTG or non- ACTG parent study of curative or suppressive HIV therapy that included an ATI.
  • * If feasible, participants should not remain co-enrolled in their respective parent study after entering A5385.
  • * 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.
  • * 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.
  • * 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.
  • * 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.
  • * 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.
  • * Barrier method
  • * Contraceptive subdermal implant
  • * Intrauterine device or intrauterine system
  • * Combined estrogen and progestogen oral contraceptive
  • * Injectable progestogen
  • * Contraceptive vaginal ring
  • * Percutaneous contraceptive patches
  • * 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.
  • * 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.
  • * Ability and willingness of participant to provide informed consent.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections,

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

Study Record Dates

2029-09-03