Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial

ConditionHIV Prevention

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age15+

SponsorUniversity of Witwatersrand, South Africa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female.

Age ≥ 15 years, inclusive, at the time of signing the informed consent.

Body weight ≥ 35 kg.

Confirmed HIV-1 infection.

Disqualifiers

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.

tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: TLD - Tenofovir Disoproxil Fumarate / Lamivudine / DolutegravirExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

At 6 Months

Secondary outcomes

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

Time frame

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

Time frame

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)

Time frame

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

Time frame

12 Months

Other outcomes

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

Changes from baseline in BMI throughout the study

Time frame

12 Months

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

Changes from baseline in lipids throughout the study

Time frame

12 Months

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

Changes from baseline in HbA1C throughout the study

Time frame

12 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Witwatersrand, South Africa

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

Source ClinicalTrials.gov

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