NCT03205696Completed
Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection
A Comprehensive Community-Based Strategy to Optimize the HIV Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
This is a strategic prospective cohort study which will measure the effects of early intensive antiretroviral therapy (ART) on the establishment and persistence of HIV-1 reservoirs and HIV-1-specific immunity in acutely /recently HIV infected youth aged 12 to 24 years as compared to newly diagnosed youth with established infection \> 6 months. Participants with newly diagnosed acute /recent HIV-1 infection will be offered enrollment into the study with immediate initiation of ART which is the current standard of care.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 101 (actual)
- First submitted
- 28 Jun 2017
- Start date
- 1 Aug 2017
- Primary completion date
- 20 Jul 2021
- Lead sponsor
- University of California, Los Angeles
- Diseases
- HIV
- NCT number
- NCT03205696
What you commit to
- Study type: Observational
- Participants enrolled: 101
- From 1 Aug 2017 to the primary completion date, 20 Jul 2021
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior ART use.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Clinical treatment with an ARV regimen less effective than those recommended by DHHS HIV clinical guidelines.
Other illness
- Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant.
- Chronic or recurrent use of medications that modify host immune response, e.g., oral or parenteral steroids, cancer chemotherapy.
Other
- Enrollment on a experimental ARV regimen
Who the study is looking for
- Male or female participants age 12 to 24 years.
- A positive HIV diagnostic assay following a negative HIV diagnostic assay obtained in the previous study visit (if subjects are enrolled in the high risk cohort study- Project 3) or within the last six months if not followed in Study 3. A positive HIV test at baseline for subjects who are included as part of the recently diagnosed arm. HIV diagnostic assays include POC rapid tests including 4th generation rapid assays, GeneXpert HIV qualitative assays, HIV antibody assays, and HIV RNA or DNA PCR assays.
- Ability and willingness to provide written informed consent.
- Willingness to initiate ART
- Willingness of treating clinician to follow DHHS guidelines for antiretroviral naïve adolescents and adults
Age in the registry: 12 years to 24 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Los Angeles LGBT Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.