Acute Human Immunodeficiency Virus Type I InfectionKILGORISNCT05372510
Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.
An observational study of Acute Human Immunodeficiency Virus Type I Infection, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Human Immunodeficiency Virus Type I Infection
- How many people
- 100 participants
- Where
- 1 siteUganda
- Study dates
- 17 Feb 2021to 31 Dec 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any females and males between 18years - No limit. * 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
MRC/UVRI & LSHTM, Uganda Research Unit,Masaka station
Masaka
FREDDIE KIBENGO, MD, +256772435251, Freddie.Kibengo@mrcuganda.org
DOREEN ASIO, Bachelors, +256772425404, Doreen.Asio@mrcuganda.org
About this study
Official title: A Pilot Study to Evaluate the Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.
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.
- Keywords
- HIV-1, immune responses, cell death, acute
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start17 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Human Immunodeficiency Virus Type I InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- International AIDS Vaccine Initiative
- Responsible party
- Principal investigator, Dr. Andrew Obuku, MRC/UVRI and LSHTM Uganda Research Unit
- Investigators
- ANDREW OBUKU, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372510
- Sponsor's protocol ID
- RGAO190401
- Acronym
- KILGORIS
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.
- ClinicalTrials.gov ID
- NCT05372510
- Acronym / sponsor ID
- KILGORIS / RGAO190401
- Keywords
- HIV-1, immune responses, cell death, acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research UnitUniversity, hospital or other
- Collaborators
- International AIDS Vaccine Initiative
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any females and males between 18years - No limit. * 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANDREW OBUKU, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Human Immunodeficiency Virus Type I Infection, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDREW OBUKU, PhD (+256772623473, Andrew.Obuku@mrcuganda.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.