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

ConditionHIV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-49
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

130 Participants
are grouped into 2 trial groups
Group A: Group 1
Group B: Group 2

Trial outcomes

Primary outcomes

1

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

Time frame
Enrollment
2

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

Time frame
Enrollment
3

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

Time frame
Enrollment
4

Evaluate in vitro potential latency reversal agents.

Evaluate in vitro potential latency reversal agents.

Time frame
Enrollment

Secondary outcomes

Other outcomes

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