Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART

Enrolling by invitationOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

December 28, 2025

Conditions
HIV-1-infectionHIV Disease ProgressionInflammationHIV
Interventions
PROCEDURE

Venipuncture

Draw of peripheral blood (about 20 ml and 40 ml, during the screening and procedure visits, respectively).

PROCEDURE

Targeted physical medical exam

"Study participants will be undergoing a physical exam where vitals will be recorded (e.g. temperature, blood pressure, heart rate). The registered nurse (RN) will also perform auscultation of heart and lungs.~Study participants will be also asked to fill out a survey with questions related to his/her medical history, current use of medications, sexual history and substance abuse."

PROCEDURE

Urine pregnancy test

Women of childbearing potential will be asked to run an urine pregnancy test during the second (procedure) visit. Pregnant women will not be allowed to participate in the study.

PROCEDURE

Anoscopy

The anoscopy is an examination using a small, rigid, tubular instrument called anoscope (also called an anal speculum). This is inserted a few inches into the rectum in order to collect some small samples of mucosal tissue. We will collect 5 rectum biopsy samples and one cytobrush.

PROCEDURE

Esophagogastroduodenoscopy (EGD)

The EGD involves looking at the esophagus, stomach, and first and second portion of the duodenum. This procedure involves the use of an endoscope to remove small tissue samples. This procedure uses conscious sedation drugs given by a vein in the arm. The procedure takes about 1½-2 hours, including time for recovery. We will collect 5 duodenal biopsies and one cytobrush.

Trial Locations (1)

98104

University of Washington Positive Research and the Gastroenterology Clinic at Harborview Medical Center, Seattle

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

lead

University of Washington

OTHER