Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans

NCT02154035 | Completed

• 2 other identifiers: 99991412314-I-N123
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Human Immunodeficiency Virus (HIV) is the virus that causes AIDS. HIV can hide in the blood for many years, even in people who have their HIV infection under control. HIV that is hiding in the blood is called the "latent HIV reservoir." Researchers want to find out more about it in this study. This knowledge may help them develop new ways to prevent or control HIV. This study will draw its participants from the Rakai Health Sciences Program in rural southwestern Uganda. Objective: \- To measure and learn about the latent HIV reservoir in Ugandans with HIV. Eligibility: \- Men and women at least 18 years of age with HIV. Design:

• Participants will have a medical history and physical exam. Their medical records will be reviewed. Researchers will ask participants about their health and recent illnesses. Participants able to get pregnant will have their urine tested for pregnancy.
• Participants will have their finger pricked to see if they have enough red blood cells to be eligible for the study.
• If eligible, participants will have blood drawn through a needle in the arm. Their blood will also be tested for other diseases.
• After the blood draw, participants will be asked to stay seated or lying down if they are not feeling well for up to 30 minutes.

Conditions

HIV

Keywords

Viral Suppression; Functional Cure; Natural History

Outcome Measures

Primary Outcomes (4)

• Explore the level of immune activation in virally suppressed HIV-infected Africans in correlation with the size of the reservoir

  Explore the level of immune activation in virally suppressed HIV-infected Africans in correlation with the size of the reservoir

  Enrollment

• Examine and measure the levels of latent HIV reservoirs in virally suppressed Ugandans and compare to that observed in Western (US) cohorts

  Examine and measure the levels of latent HIV reservoirs in virally suppressed Ugandans and compare to that observed in Western (US) cohorts

  Enrollment

• Determine the role of endemic infectious diseases, nadir CD4 count, and length of fully suppressive therapy on latent HIV reservoir size

  Determine the role of endemic infectious diseases, nadir CD4 count, and length of fully suppressive therapy on latent HIV reservoir size

  Enrollment

• Evaluate in vitro potential latency reversal agents.

  Evaluate in vitro potential latency reversal agents.

  Enrollment

Study Arms (2)

Group 1

HIV-infected patients on ART with suppressed viral loads, defined as \<40 copies per ml over a period of 10-18 months.

Group 2

HIV-infected patients on ART with suppressed viral loads, defined as \<40 copies per ml over a period of 10-18 months.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will draw its participants from an NIH International Center for Excellence in Research (ICER) site, located at the Rakai Health Sciences Program (RHSP) in rural southwestern Uganda. Since 1994, over 12,000 adults aged 15-49 years of age have been under annual surveillance in an open cohort, the Rakai Community Cohort Study (RCCS). Within the RCCS, the Rakai Program has conducted multiple observational, basic science, behavioral and operations research studies, and has conducted complex community and individual randomized HIV and sexually transmitted disease (STD) prevention trials.

You may qualify if:

• At least 18 years of age
• Hemoglobin \>11g/dL as assessed by fingerstick rapid test
• Weight \>40 kilograms
• A historical diagnosis of HIV infection as indicated by any positive serological test (ELISA, HIV rapid test, or Western Blot)
• Virally suppressed as defined as at least two historical viral loads \<40 copies/ml obtained between 10-18 months apart, and no intervening detectable viral load result \>= 40 copies/ml obtained during this period
• Most recent historical viral load result obtained within a year prior to the screening visit
• Willingness to undergo genetic testing

You may not qualify if:

• Women who are pregnant will be excluded as the required blood draw may cause anemia and because of perturbations due to hormonal or immunosuppressive states that could impact the reservoir.
• Inability to follow study instructions or to provide informed consent
• Any condition deemed by the investigators to be a contraindication to study participation including active, serious infections (other than HIV infection) during the 2 weeks prior to enrollment.
• Malignancies of any kind (e.g., Kaposi's sarcoma)
• Therapy with systemic steroids, immunosuppressants or immunomodulating agents
• Coagulation defects or other serious bleeding disorders
• Current use of medications which could affect clotting.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Rakai Health Sciences Program Uganda Virus Research Institute

Kalisizo, Uganda

Location

Related Publications (2)

• Ho YC, Shan L, Hosmane NN, Wang J, Laskey SB, Rosenbloom DI, Lai J, Blankson JN, Siliciano JD, Siliciano RF. Replication-competent noninduced proviruses in the latent reservoir increase barrier to HIV-1 cure. Cell. 2013 Oct 24;155(3):540-51. doi: 10.1016/j.cell.2013.09.020. Epub 2013 Oct 24.

  PMID: 24243014 BACKGROUND

• Wightman F, Ellenberg P, Churchill M, Lewin SR. HDAC inhibitors in HIV. Immunol Cell Biol. 2012 Jan;90(1):47-54. doi: 10.1038/icb.2011.95. Epub 2011 Nov 15.

  PMID: 22083528 BACKGROUND

Study Officials

• Steven J Reynolds, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2014
• First Posted: June 3, 2014
• Study Start: May 31, 2014
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: May 1, 2026

Record last verified: 2025-06-26

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)