Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans (NCT02154035) | Clinical Trial Compass
CompletedNot Applicable
Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans
Uganda90 participantsStarted 2014-05-31
Plain-language 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.
Who can participate
Age range18 Years – 49 Years
SexALL
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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
What they're measuring
1
Explore the level of immune activation in virally suppressed HIV-infected Africans in correlation with the size of the reservoir
Timeframe: Enrollment
2
Examine and measure the levels of latent HIV reservoirs in virally suppressed Ugandans and compare to that observed in Western (US) cohorts
Timeframe: Enrollment
3
Determine the role of endemic infectious diseases, nadir CD4 count, and length of fully suppressive therapy on latent HIV reservoir size
Timeframe: Enrollment
4
Evaluate in vitro potential latency reversal agents.
Timeframe: Enrollment
Trial details
NCT IDNCT02154035
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. 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.