NCT05085171 An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease
| NCT ID | NCT05085171 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Makerere University |
| Condition | The Study Will Focus on Assessing the Survival Benefit on an Enhanced Package of Care for Patients With Advanced HIV Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2022-05-04 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,400 participants in total. It began in 2022-05-04 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.
Eligibility Criteria
Inclusion Criteria: * Age \>18 years * CD4\<200 cells/µL * Ability and willingness to give informed consent for the enhanced package of care arm. Exclusion Criteria: * Known virologic suppression (viral load \<1000 copies/mL) within prior 3 months * Cannot or unlikely to attend regular clinic visits
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05085171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying The Study Will Focus on Assessing the Survival Benefit on an Enhanced Package of Care for Patients With Advanced HIV Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05085171 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,400 participants.
Is NCT05085171 currently recruiting?
Yes, NCT05085171 is actively recruiting participants. Contact the research team at radha@umn.edu for enrollment information.
Where is the NCT05085171 trial being conducted?
This trial is being conducted at Kampala, Uganda.
Who is sponsoring the NCT05085171 clinical trial?
NCT05085171 is sponsored by Makerere University. The trial plans to enroll 2,400 participants.
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