Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2020

Primary Completion Date

September 30, 2021

Study Completion Date

September 30, 2021

Conditions
Medication AdherenceHIV
Interventions
DRUG

dolutegravir oral tablet 50mg

"Tivicay® (dolutegravir, DTG), a HIV-1 integrase strand transfer inhibitor (INSTI), is FDA-approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 30kg. Tivicay® 50mg tablets \[GlaxoSmithKline\] are yellow, round, film-coated, biconvex tablets debossed with SV 572 on one side and 50 on the other side. The inactive ingredients in each tablet are D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients iron oxide yellow macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide."

DRUG

emtricitabine/tenofovir alafenamide oral tablet 200mg/25mg

"Descovy® (emtricitabine/tenofovir alafenamide, FTC/TAF) is a combination of two HIV nucleoside analog reverse transcriptase inhibitors (NRTIs) FDA-approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35kg. Descovy® 200 mg/25 mg tablets \[Gilead\] are blue, rectangular-shaped, and film-coated with GSI debossed on one side and 225 on the other side. The inactive ingredients are croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."

DRUG

tenofovir disoproxil fumarate oral tablet 300mg

"Viread® (tenofovir DF, TDF) is a nucleotide analog HIV-1 reverse transcriptase inhibitor and a hepatitis B reverse transcriptase inhibitor FDA-approved for the treatment of HIV-1 infection in combination with other antiretroviral agents and for the treatment of chronic hepatitis B in adults and pediatric patients 2 years of age and older weighing at least 10kg. Viread® 300mg tablets \[Gilead\] are almond-shaped, light blue, film-coated tablets containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with GILEAD and 4331 on one side and with 300 on the other side. The inactive ingredients in each tablet are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Viread® 300mg tablets are coated with Opadry II Y-30-10671-A, which contains FD\&C blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin."

DRUG

lamivudine oral tablet 300mg

"Lamivudine (Epivir®, 3TC) is a nucleoside analogue reverse transcriptase inhibitor FDA-approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients at least 3 months of age. Lamivudine 300mg tablets \[Apotex Inc.\] are gray, modified diamond-shaped, film-coated, and engraved with LMV 300 on one side and APO on the reverse side. Inactive ingredients are black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, polyethylene glycol, and titanium dioxide."

Trial Locations (1)

15213

HIV/AIDS Clinical Research Unit / University of Pittsburgh, Pittsburgh

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Rhonda Brand

OTHER

NCT04302896 - Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs | Biotech Hunter | Biotech Hunter