Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial

NCT06485154 | Active Not Recruiting Phase 4

• 1 other identifier: EZ-BB-036
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV Prevention

Keywords

Pre-Exposure Prophylaxis (PrEP); Antiretroviral therapy; Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

  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

  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

  12 Months

• To investigate the development of HIV drug resistance over the duration of the trial of HIV treatment with TLD

  12 Months

Other Outcomes (3)

• To conduct investigation on the effects of IMP on metabolic health over 12 months

  12 Months

• To conduct investigation on the effects of IMP on metabolic health over 12 months

  12 Months

• To conduct investigation on the effects of IMP on metabolic health over 12 months

  12 Months

Study Arms (1)

TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir

EXPERIMENTAL

The IMP is defined as any investigational marketed product to be administered to a study participant according to the study protocol. Participants will all receive TLD as detailed below. Treatment will be open-label, and drugs will be dispensed at intervals as specified in the Schedule of Events. Investigational Product Tenofovir disoproxil fumarate / lamivudine / dolutegravir Dosage Formulation 300 mg / 300 mg / 50 mg fixed dose combination tablet Route of Administration Oral Dosing Instructions 1 tablet (300/300/50 mg TDF/3TC/DTG) daily

Drug: TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir

Interventions

TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir DRUG

Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, a combination of dolutegravir (integrase strand transfer inhibitor \[INSTI\]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside reverse transcriptase inhibitors), is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg

Also known as: Acriptega

TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Age ≥ 15 years, inclusive, at the time of signing the informed consent.
• Body weight ≥ 35 kg.
• Confirmed HIV-1 infection.
• Exposure to at least one dose of CAB-LA PrEP in the past 12 months.
• Consent to initiation of ART.
• Estimated glomerular filtration rate (eGFR) \> 50 min/mL

You may not qualify if:

• Any previous exposure to DTG.
• Concurrent or recent (within the preceding 3 months) participation in another interventional clinical trial with a compound likely to interfere with any of the investigational medicinal products.
• Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.
• Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study:
• tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;
• anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);
• herbal products (e.g., St John's Wort).
• Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and/or protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.
• Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results. This including inability or an unwillingness to be followed up for the study period.

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (3)

Ezintsha, a division of Wits Health Consortium

Johannesburg, Gauteng, 2193, South Africa

Location

Africa Health Research Institute (AHRI)

Durban, KwaZulu-Natal, 3935, South Africa

Location

Desmond Tutu Health Foundation

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Interventions

Lamivudine; dolutegravir

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• FRANCOIS WD VENTER, PhD

  Ezintsha, a division of Wits Health Consortium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Age ≥ 15 years, inclusive, at the time of signing the informed consent.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director: Ezintsha

Model Details: Oral - 1 tablet (300/300/50 mg TDF/3TC/DTG) daily

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 3, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication
• Access Criteria: Anyone who wishes to access the data

Locations

ZA (3)