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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT02154035
• Date of registration: 31/05/2014
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans
• Scientific title: Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans
• Date of first enrolment: May 31, 2014
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02154035
• Study type: Observational

Countries of recruitment

Uganda

Contacts

• Name: Steven J Reynolds, M.D.
• Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

1. At least 18 years of age

2. Hemoglobin >11g/dL as assessed by fingerstick rapid test

3. Weight >40 kilograms

4. A historical diagnosis of HIV infection as indicated by any positive serological
test (ELISA, HIV rapid test, or Western Blot)

5. 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

6. Most recent historical viral load result obtained within a year prior to the
screening visit

7. Willingness to undergo genetic testing

EXCLUSION CRITERIA:

1. 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

2. Inability to follow study instructions or to provide informed consent

3. 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

4. Malignancies of any kind (e.g., Kaposi's sarcoma)

5. Therapy with systemic steroids, immunosuppressants or immunomodulating agents

6. Coagulation defects or other serious bleeding disorders

7. Current use of medications which could affect clotting



Age minimum: 18 Years
Age maximum: 49 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Primary Outcome(s)

Explore the level of immune activation in virally suppressed HIV-infected Africans in correlation with the size of the reservoir [Time Frame: Enrollment]

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]

Determine the role of endemic infectious diseases, nadir CD4 count, and length of fully suppressive therapy on latent HIV reservoir size [Time Frame: Enrollment]

Secondary ID(s)

999914123

14-I-N123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)