Better treatment options for adults whose HIV pill combination (TLD) isn't working in sub‑Saharan Africa
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on TLD in Sub-Saharan Africa
['FUNDING_R01'] · MASSACHUSETTS GENERAL HOSPITAL · NIH-11136401
This project compares personalized care approaches to help adults with HIV in sub‑Saharan Africa whose first‑line TLD medicine has stopped keeping the virus suppressed.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | MASSACHUSETTS GENERAL HOSPITAL (nih funded) |
| Locations | 1 site (BOSTON, UNITED STATES) |
| Trial ID | NIH-11136401 on ClinicalTrials.gov |
What this research studies
You would join a randomized trial that tests a personalized care plan versus current standard care for people on TLD who have detectable HIV in their blood. The personalized plan uses a quick urine test for tenofovir (to check recent pill taking), genotypic resistance testing, and tailored changes based on adherence, side effects, and patient preferences. Participants are randomly assigned to one of the approaches and followed to see who regains viral suppression while staying on simple once‑daily regimens when possible. The goal is to find practical, patient‑friendly ways to manage treatment failure and avoid unnecessary switches to more complex medicines.
Who could benefit from this research
Good fit: Adults (age 21 and older) living with HIV in sub‑Saharan Africa who are currently taking TLD and have confirmed virologic failure are the intended participants.
Not a fit: People who are virally suppressed on TLD, children, or people outside the trial sites in sub‑Saharan Africa would not directly benefit from participating in this trial.
Why it matters
Potential benefit: If successful, this could help people keep or return to an effective, once‑daily HIV regimen by matching care to the real cause of treatment failure.
How similar studies have performed: Components like adherence support and resistance testing have helped in some settings, but this is the first randomized trial combining point‑of‑care drug testing with genotype‑guided, individualized management for TLD failure.
Where this research is happening
BOSTON, UNITED STATES
- MASSACHUSETTS GENERAL HOSPITAL — BOSTON, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: MCCLUSKEY, SUZANNE — MASSACHUSETTS GENERAL HOSPITAL
- Study coordinator: MCCLUSKEY, SUZANNE
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Acquired Immune Deficiency Syndrome, Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome, Acquired Immunodeficiency Syndrome Virus