About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial 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.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
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
Evaluate in vitro potential latency reversal agents.
Evaluate in vitro potential latency reversal agents.
Sponsors and contacts
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National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator