An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease
Recruiting
Phase 3
Interventional Study
The Study Will Focus on Assessing the Survival Benefit on an Enhanced Package of Care for Patients With Advanced HIV Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 2,400 (estimated)
- Sponsor
- Makerere University · Other
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About This Trial
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.
Trial Locations
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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 vis…
Contacts