Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
NCT Number: NCT06485154
Acronym: PICASSO
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: HIV Prevention
Interventions: DRUG: TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
Sponsor: University of Witwatersrand, South Africa
Collaborators: Bill and Melinda Gates Foundation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-01
Completion Date: 2026-08-31
Locations: Ezintsha, a division of Wits Health Consortium, Johannesburg, Gauteng, 2193, South Africa|Africa Health Research Institute (AHRI), Durban, KwaZulu-Natal, 3935, South Africa|Desmond Tutu Health Foundation, Cape Town, Western Cape, 7925, South Africa

Summary:
This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months. Participants will be followed up for a period of 12 months from enrolment.

Primary Outcome Measures: To evaluate the efficacy of TLD as first-line antiretroviral therapy (ART) in participants with HIV-1 infection and CAB-LA PrEP exposure in the past 12 months, Proportion of participants with virologic suppression (plasma HIV-1 RNA levels \< 50 cp/mL) at Month 6, At 6 Months
Secondary Outcome Measures: To describe the epidemiology (i.e., prevalence and correlates) of HIV drug resistance patterns in participants with HIV-1 infection and prior CAB-LA PrEP exposure, Proportion of participants with unsuppressed viral loads (HIV-1 RNA levels ≥ 50 cp/mL and ≥ 1000 cp/mL) at Month 6 and Month 12, 6 and 12 Months|To describe the epidemiology (i.e., prevalence and correlates) of HIV drug resistance patterns in participants with HIV-1 infection and prior CAB-LA PrEP exposure, Time to virologic suppression, 12 Months|To describe the epidemiology (i.e., prevalence and correlates) of HIV drug resistance patterns in participants with HIV-1 infection and prior CAB-LA PrEP exposure, Prevalence of HIV genotypic resistance to NRTI and INSTI drug classes at screening (baseline), 12 Months|To describe the epidemiology (i.e., prevalence and correlates) of HIV drug resistance patterns in participants with HIV-1 infection and prior CAB-LA PrEP exposure, Comparative prevalence of INSTI drug resistance in those with HIV and CAB-LA exposure and HIV acquisition deemed to occur prior to initiation of PrEP, during PrEP therapy, or after cessation of therapy, 12 Months|To investigate the development of HIV drug resistance over the duration of the trial of HIV treatment with TLD, Assessment of genotypic drug resistance in participants with confirmed virologic failure (HIV-1 RNA ≥ 200 cp/mL on 2 or more occasions) throughout study duration, 12 Months|To evaluate the safety of TLD over 12 months, Incidence of SAEs and DAIDS-defined Grade 3 and Grade 4 AEs, throughout study duration, including AEs considered related to the IMP, 12 Months|To evaluate the safety of TLD over 12 months, Proportion of participants discontinuing treatment due to AEs, 12 Months|To evaluate the safety of TLD over 12 months, Assessment of absolute values and changes in laboratory parameters over 12 months, 12 Months
Other Outcome Measures: To conduct investigation on the effects of IMP on metabolic health over 12 months, Changes from baseline in BMI throughout the study, 12 Months|To conduct investigation on the effects of IMP on metabolic health over 12 months, Changes from baseline in lipids throughout the study, 12 Months|To conduct investigation on the effects of IMP on metabolic health over 12 months, Changes from baseline in HbA1C throughout the study, 12 Months