NCT02154035Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 130 (estimated)
First submitted: 31 May 2014
Start date: May 2014
Primary completion date: Jun 2027
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Diseases: HIV
NCT number: NCT02154035

What you commit to

Study type: Observational
Planned participants: 130
From May 2014 to the primary completion date, Jun 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.
Therapy with systemic steroids, immunosuppressants or immunomodulating agents
Current use of medications which could affect clotting.

Other illness

Malignancies of any kind (e.g., Kaposi's sarcoma)
Coagulation defects or other serious bleeding disorders

Other

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

Criteria the registry did not label

INCLUSION CRITERIA:
- 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

Age in the registry: 18 years to 49 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Rakai Health Sciences Program Uganda Virus Research Institute Coordinator of this site? Confirm its status	Kalisizo	Uganda	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.