HIV PreventionPhase 4PICASSONCT06485154
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
A Phase 4 study testing TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir in people with HIV Prevention, run by University of Witwatersrand, South Africa at 3 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV Prevention
- What is being tested?
- TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 1 Jun 2024to 31 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa3 sites, 3 recruiting
- Recruiting
Desmond Tutu Health Foundation
Cape Town, Western Cape, 7925
ELZETTE Rousseau, PHD, 021 301 2020, Elzette.Rousseau@hiv-research.org.za
LINDA-GAIL BEKKER, MB, 021 301 2020, Linda-Gail.Bekker@hiv-research.org.za
- Recruiting
Africa Health Research Institute (AHRI)
Durban, KwaZulu-Natal, 3935
MARK SIEDNER, MBBCh, 035 251 0650, mark.siedner@ahri.org
LIMAKATSO LEBINA, MBBCh, 035 251 0650
- Recruiting
Ezintsha, a division of Wits Health Consortium
Johannesburg, Gauteng, 2193
NONKULULEKO MASHABANE, BPharm, 0110844953, nmashabane@ezintsha.org
BUKANI X DYARIWE, 0110844961, bdyariwe@ezintsha.org
About this study
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.
Read the detailed description
Study participants are HIV-1 infected adult patients recruited. A target of 100 participants will be enrolled and started on Tenofovir, Lamivudine, and Dolutegravir at enrolment. Clinical assessments for these participants will be conducted throughout the study as per the Schedule of Events.
This will be a two-phase interventional study to identify the optimally safe and effective Antiretroviral Therapy regimen for individuals with newly detected Human Immunodeficiency Virus infection after Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure. In the Initial Phase, the investigator will demonstrate proof of principle for the use of standardized Antiretroviral Therapy regimens in combination with pre-treatment genotypic drug resistance testing to achieve virologic suppression in individuals with prior Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure and understand drug resistance patterns prior to Antiretroviral Therapy initiation. To do this, the investigator will use a single-arm, interventional design using Tenofovir, Lamivudine, and dolutegravir. This supports programmatic rollout, particularly in developing countries where baseline Human Immunodeficiency Virus genotyping is not performed prior to initiation of Antiretroviral Therapy. The over-arching goals of Phase I are to determine the feasibility of our study design to recruit people with detectable Human Immunodeficiency Virus after prior use of Cabotegravir-Long-acting Pre-Exposure Prophylaxis failure and to estimate virologic suppression rates with current first-line standard of care, Tenofovir, Lamivudine, and Dolutegravir therapy.
At the conclusion of the Initial Phase, data will be assessed to determine the need for and optimal design of a potential Second Phase (the details of which will not be described in this protocol). Should the investigator find sub-optimal virologic suppression rates on Tenofovir, Lamivudine, and Dolutegravir regimens in this trial, the investigator would then proceed to the Second Phase in which the investigator will compare Darunavir/Ritonavir based Antiretroviral Therapy with Tenofovir, Lamivudine, and Dolutegravir in an open-label randomized, non-inferiority clinical trial. The aim of the second phase will be to determine whether an alternative to the predominant first-line regimen in much of the world will be required to optimise virologic suppression for this population.
- Conditions
- HIV Prevention
- Being tested
- TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Antiretroviral therapy, Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLD - Tenofovir Disoproxil Fumarate / Lamivudine / DolutegravirDrug
Also called Acriptega
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Proportion of participants with unsuppressed viral loads (HIV-1 RNA levels ≥ 50 cp/mL and ≥ 1000 cp/mL) at Month 6 and Month 12
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 12 Months
To evaluate the safety of TLD over 12 months
Proportion of participants discontinuing treatment due to AEs
Measured: 12 Months
To evaluate the safety of TLD over 12 months
Assessment of absolute values and changes in laboratory parameters over 12 months
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Oral - 1 tablet (300/300/50 mg TDF/3TC/DTG) daily
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Professor Francois Venter, University of Witwatersrand, South Africa
- Investigators
- FRANCOIS WD VENTER, PhD, Study director, Ezintsha, a division of Wits Health Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485154
- Sponsor's protocol ID
- EZ-BB-036
- Acronym
- PICASSO
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
- ClinicalTrials.gov ID
- NCT06485154
- Acronym / sponsor ID
- PICASSO / EZ-BB-036
- Conditions
- HIV Prevention
- Keywords
- Pre-Exposure Prophylaxis (PrEP), Antiretroviral therapy, Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study participants are HIV-1 infected adult patients recruited. A target of 100 participants will be enrolled and started on Tenofovir, Lamivudine, and Dolutegravir at enrolment. Clinical assessments for these participants will be conducted throughout the study as per the Schedule of Events.
This will be a two-phase interventional study to identify the optimally safe and effective Antiretroviral Therapy regimen for individuals with newly detected Human Immunodeficiency Virus infection after Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure. In the Initial Phase, the investigator will demonstrate proof of principle for the use of standardized Antiretroviral Therapy regimens in combination with pre-treatment genotypic drug resistance testing to achieve virologic suppression in individuals with prior Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure and understand drug resistance patterns prior to Antiretroviral Therapy initiation. To do this, the investigator will use a single-arm, interventional design using Tenofovir, Lamivudine, and dolutegravir. This supports programmatic rollout, particularly in developing countries where baseline Human Immunodeficiency Virus genotyping is not performed prior to initiation of Antiretroviral Therapy. The over-arching goals of Phase I are to determine the feasibility of our study design to recruit people with detectable Human Immunodeficiency Virus after prior use of Cabotegravir-Long-acting Pre-Exposure Prophylaxis failure and to estimate virologic suppression rates with current first-line standard of care, Tenofovir, Lamivudine, and Dolutegravir therapy.
At the conclusion of the Initial Phase, data will be assessed to determine the need for and optimal design of a potential Second Phase (the details of which will not be described in this protocol). Should the investigator find sub-optimal virologic suppression rates on Tenofovir, Lamivudine, and Dolutegravir regimens in this trial, the investigator would then proceed to the Second Phase in which the investigator will compare Darunavir/Ritonavir based Antiretroviral Therapy with Tenofovir, Lamivudine, and Dolutegravir in an open-label randomized, non-inferiority clinical trial. The aim of the second phase will be to determine whether an alternative to the predominant first-line regimen in much of the world will be required to optimise virologic suppression for this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Oral - 1 tablet (300/300/50 mg TDF/3TC/DTG) daily
| Arm | Type | Receives |
|---|---|---|
| TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir | Experimental | Drug: TLD - Tenofovir Disoproxil Fumarate / Lamivudine / DolutegravirThe 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLD - Tenofovir Disoproxil Fumarate / Lamivudine / DolutegravirAlso: AcriptegaDolutegravir, 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 | Drug | TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir |
Primary outcome
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
Time frame: At 6 Months
Proportion of participants with virologic suppression (plasma HIV-1 RNA levels < 50 cp/mL) at Month 6
8 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
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 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
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
Time frame: 12 Months
To investigate the development of HIV drug resistance over the duration of the trial of HIV treatment with TLD
Time frame: 12 Months
To evaluate the safety of TLD over 12 months
Time frame: 12 Months
To evaluate the safety of TLD over 12 months
Time frame: 12 Months
To evaluate the safety of TLD over 12 months
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FRANCOIS WD VENTER, PhD study director
Ezintsha, a division of Wits Health Consortium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir in people with HIV Prevention, run by University of Witwatersrand, South Africa at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BUKANI X DYARIWE (0110844961, bdyariwe@ezintsha.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.