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

NCT04938518 | Unknown

• 1 other identifier: SERU Protocol no. 3620
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

• Types of ART regimen, and the number of aviremic patients with detectable viral loads

  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.

  12 Months

• Types and Levels of Cytokines as measured by Multiplex Immunoassays

  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.

  36 Months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenya Medical Research Institute: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, 00200, Kenya

RECRUITING

Related Publications (23)

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  PMID: 25587657 BACKGROUND

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  PMID: 25101529 BACKGROUND

• PEPFAR, "Kenya Country Operational Plan," 2015.

  BACKGROUND

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  PMID: 24706775 BACKGROUND

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  PMID: 22313953 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected from participants for plasma HIV-1 RNA, PBMCs harvesting, CD4 quantification and and cytokine analysis

Study Officials

• Edward K Maina, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward K Maina, PhD

CONTACT

+254791757849; emaina02@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: June 24, 2021
• Study Start: May 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)