Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans
Recruiting · NCT02154035 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Rakai Health Sciences Program Uganda Virus Research Institute - Kalisizo, Uganda