Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.

A Pilot Study to Evaluate the Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05372510

Acronym

KILGORIS

Enrollment

100

Registered

2022-05-12

Start date

2021-02-17

Completion date

2022-12-31

Last updated

2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Human Immunodeficiency Virus Type I Infection

Keywords

HIV-1, immune responses, cell death, acute

Brief summary

It is only between peak viremia and viral setpoint in natural acute HIV-1 infection that the immune response overwhelms viral replication resulting in a plasma viral load decline. The aim will be to characterize these immune responses, how they develop and their progeny. This will require the need to identify HIV-1 infected individuals before peak viremia and follow them to post viral setpoint. This protocol describes a pilot study to evaluate the feasibility of identifying, enrolling and following acute and early HIV-1 infected individuals from voluntary counselling and testing centres in Masaka, Bukomansimbi, Kalungu, Lwengo, Sembababule and Lyantonde districts.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Females and males. * Able and willing to provide informed consent. * Willing to undergo HIV testing using GeneX pert Viral Load assay. * Able and willing to provide accurate locator information for tracking purposes and willing to be contacted by study staff. * Willing to complete interviewer administered questionnaires on risk factors and if infected, questions related to the route and timing of exposure.

Exclusion criteria

Has any condition that in the opinion of the principal investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives. * Participation in a current clinical trial unless approved by the investigators and IAVI medical monitor.

Design outcomes

Primary

Measure	Time frame
To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative.	12 months

Countries

Uganda

Contacts

Primary ContactANDREW OBUKU, PhD

Andrew.Obuku@mrcuganda.org+256772623473

Backup ContactFREDDIE KIBENGO, MD

Freddie.Kibengo@mrcuganda.org+256772435251

Outcome results