Status:
UNKNOWN
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
Lead Sponsor:
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Collaborating Sponsors:
Brigham and Women's Hospital
Weill Medical College of Cornell University
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for pa...
Detailed Description
With current approaches to HIV care, patients generally do not qualify for expedited services until they have been in care for 6 to 12 months. Once they have achieved an undetectable viral load and/or...
Eligibility Criteria
Inclusion
- Documentation of positive HIV status (test conducted at GHESKIO)
- Age ≥18 years of age
- Eligible for TLD regimen, according to Haitian Ministry of Health guidelines
- Initiate ART within 3 days prior to enrollment
- Lives in Port-au-Prince metropolitan area
- Ability and willingness to give written informed consent
- Use of reliable contraception (for women of childbearing potential);
- Physician-confirmed WHO Stage 1 or 2 disease
Exclusion
- Not ART-naïve (history of ART for any duration in the past)
- World Health Organization Stage 3 or 4 disease;
- Pregnancy or breastfeeding at the screening visit;
- Planning to become pregnant during the study period;
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
- Creatinine clearance (CrCl) \<50 within 1 month prior to study entry;
- ALT and/or AST\> 5X upper limit of normal (ULN) within 1 month prior to study entry;
- Planning to transfer care to another clinic during the study period
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 29 2022
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04311944
Start Date
September 1 2020
End Date
May 29 2022
Last Update
July 31 2020
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