Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD

HIV-1-infection Clinical Trial

Official title:

Early Fast-Track Versus Standard Care for Persons With HIV Initiating Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir (TLD) in Haiti: A Pilot Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04311944
• Other study ID #: 212336
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 29, 2022

Study information

• Verified date: July 2020
• Source: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
• Contact: Colette Guiteau, MD
• Phone: 3449-3596
• Email: colette0786[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 patients who are initiating a dolutegravir-based antiretroviral therapy regimen.

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 high adherence, patients qualify for expedited services with fewer clinic visits. The problem with this approach is that it's time-intensive early in ART care, when attrition rates are highest. A potential solution to this problem is to provide earlier fast-track care for patients on dolutegravir-based regimens with viral suppression. This strategy is feasible due to the high potency and rapid declines in viral load with dolutegravir-based regimens.

We will compare a strategy of early fast-track care (8 to 12 weeks, for patients with viral suppression) versus standard initiation of fast-track care (after 6 months in care, with viral suppression). All participants will receive the same ART regimen, the combination regimen of Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 242
• Est. completion date: May 29, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Other:
• Early fast-track care
Participants will be eligible for fast-track care at 8 weeks if their HIV-1 RNA is <200 copies/mL and they meet other eligibility criteria. If HIV-1 RNA is 200 copies/mL or higher at 8 weeks, then it will be repeated at 12 weeks, and those with HIV-1 RNA <200 copies will then be eligible for fast-track care, if they meet other eligibility criteria.
• Standard (deferred fast-track) care
Participants will be eligible for fast-track care at 24 weeks, if their HIV-1 RNA is <200 copies.mL, and they meet other eligibility criteria.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic	Brigham and Women's Hospital, Florida International University, Weill Medical College of Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression - 200 copies/mL cut-off	Proportion of participants with HIV-1 RNA <200 copies/mL	48 weeks after study enrollment
Secondary	Viral suppression - 50 copies/mL cut-off	Proportion of participants with HIV-1 RNA <50 copies/mL	48 weeks after study enrollment
Secondary	Viral suppression - 1000 copies/mL cut-off	Proportion of participants with HIV-1 RNA <1000 copies/mL	48 weeks after study enrollment
Secondary	Adherence of at least 90%	Adherence to antiretroviral therapy of at least 90% as measured by pharmacy refill records	48 weeks after enrollment
Secondary	Medication tolerability	Proportion of participants discontinuing tenofovir disoproxil/lamivudine/dolutegravir regimen	48 weeks after enrollment
Secondary	Cost	Total cost of early fast-track and standard (deferred fast-track) care from the health center perspective	48 weeks after enrollment
Secondary	Time in clinic	Median time in clinic	48 weeks after enrollment