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Latent HIV-1, Viral Suppress and Hope for HIV Cure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04938518
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : July 20, 2021
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
Dr. Edward Maina, Kenya Medical Research Institute

Brief Summary:
In 2014, the Joint United Nations Program on HIV/AIDS (UNAIDS) issued treatment goals for Human Immunodeficiency Virus (HIV), the 90-90-90 target. It is important to track success results at each stage of the HIV continuum of care to evaluate progress towards the 90-90-90 target. Although ART can suppress HIV-1 infection to undetectable levels of plasma viremia, HIV DNA integrate and persist in resting CD4+ T cells. Most of the HIV DNA in these cells is defective and cannot cause infection. However, latent HIV-1 genomes that encode replication-competent virus can resurface once ART is discontinued. This latent reservoir is believed to be the largest impediment to a cure by ART alone. There is need for expansion of research examining HIV latency in the context of sustained viral suppression with an eye towards developing a possible cure regimen that could be used on a large scale. To date, there have been no systematic studies to quantify the latent reservoir in virally suppressed HIV-infected patients in Africa. Detecting how much of the inducible virus is left in the human body after ART poses the greatest challenge to fully curing HIV. This study is designed to enroll 222 virally suppressed HIV infected men and women, who will be prospectively followed to document antiviral cocktail, viral suppression and incidences of rebound, measure the size of the latent HIV reservoir and examine the immunological correlates of the latent reservoir. Data generated through this study will provide a clear framework for high-burden countries to reduce gaps at each stage of the HIV continuum of care, maximize linkage, retention and health outcomes.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 222 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Investigation of the Impact of Inducible, Replication-competent Latent HIV-1 as an Impediment to HIV/AIDS Cure in the Context of Sustained Viral Suppression
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Types of ART regimen, and the number of aviremic patients with detectable viral loads [ Time Frame: 12 Months ]
    This will entail abstracting patients' data from medical record to capture subjects' demographic data, ART regimen that the subjects had been using, viral loads measurements, duration of the ART regimen. This data will be analysed using STATA and Graphpad Prisim software to determine whether there is viral rebound in the period under study. The durability of viral suppression will be determined.

  2. Types and Levels of Cytokines as measured by Multiplex Immunoassays [ Time Frame: 36 Months ]
    Immunoassays will be carried out on blood samples from consenting patients to assess cytokine profiles. The types and levels of cytokines will be related to viral load levels and other factors. The number of aviremic patients with competent immune function will be determined.

Biospecimen Retention:   Samples With DNA
Blood will be collected from participants for plasma HIV-1 RNA, PBMCs harvesting, CD4 quantification and and cytokine analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study will utilize HIV-1 infected patients (18 to 70 years) attending HIV care and treatment facilities in three counties of Meru, Kilifi, and Mombasa. Analysis of medical records to document ART cocktail will be performed. Latent HIV will be determined in patients with viral suppression, defined according to WHO guideline 2016, and followed for 24 months to monitor incidences of viral rebound.

Inclusion Criteria:

  • • HIV-1 infected patients attending HIV care and treatment facilities in three counties of Meru, Kilifi, and Mombasa.

    • Registered at the comprehensive care centre
    • Currently prescribed ART
    • Able to understand consent process
    • Have a viral load threshold of <1000 copies/mL or with viral loads below the limit of detection

Exclusion Criteria:

  • • High-risk pregnancy for reasons other than HIV status (e.g., pregnancy complications, preeclampia, gestational diabetes, preterm labor)

    • Have known history of chronic diseases
    • Self-reported participation in another HIV-related study
    • Both participant and guardian unable to understand consent process
    • Planning on relocating out of study sites over the next 12 months
    • Patients of tender years(<18 yr) or extreme old age (>70 yr)
    • Incapacitated patients will not be recruited

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04938518

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Contact: Edward K Maina, PhD +254791757849

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Kenya Medical Research Institute Recruiting
Nairobi, Kenya, 00200
Contact: Edward K Maina, PhD    +254791757849   
Principal Investigator: Edward K Maina, PhD         
Sponsors and Collaborators
Kenya Medical Research Institute
European and Developing Countries Clinical Trials Partnership (EDCTP)
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Principal Investigator: Edward K Maina, PhD Kenya Medical Research Institute
Publications of Results:
Other Publications:
NASCOP, "Kenya AIDS Indicator Survey 2012:," Prelim. Rep., 2013.
C. Orrell, "Antiretroviral adverse drug reactions and their management:," SA J CPD, vol. 26, no. 9, pp. 234-237, 2011.
G. Meintjes, G. Maartens, A. Boulle, F. Conradie, E. Goemaere, and E. Hefer, "Adult antiretroviral therapy guideline.," South Afr J HIV Med, vol. 15, no. 4, pp. 121-143, 2014.
PEPFAR, "Kenya Country Operational Plan," 2015.

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Responsible Party: Dr. Edward Maina, Principal Investigator, Kenya Medical Research Institute Identifier: NCT04938518    
Other Study ID Numbers: SERU Protocol no. 3620
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No