HIV InfectionsRESOLVENCT05373758
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
A study testing Individualized Care treatment strategy and Immediate Switch in people with HIV Infections and AIDS, run by Massachusetts General Hospital at 3 sites in 2 countries.
Trial summary
The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV Infections, AIDS, Virologic Failure
- What is being tested?
- Individualized Care treatment strategy and Immediate Switch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 7 Feb 2024to 30 Jun 2027
- Phase
- Interventional
- 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
- Age 15 years and above
- Enrolled in HIV care at one of the study clinics
- History of two HIV-1 RNA viral load measurements >1,000 copies/mL while on TLD
- On TLD for at least 12 months
- Lives within 100 kilometers of study clinic
- Pregnant women are eligible for enrollment.
Who cannot join
- Plans to transfer out of the clinic within the next 48 weeks
- Plans to move out of the study catchment area within the next 48 weeks
- As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Uganda2 sites, 2 recruiting
- Recruiting
Mbarara City Clinic
Mbarara
Winnie Muyindike
Winnie Muyindike
- Recruiting
Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic
Mbarara
Winnie Muyindike
Winnie Muyindike
South Africa1 site, 1 recruiting
- Recruiting
RK Khan Hospital Clinic
Durban
Richard Lessells
Richard Lessells
About this study
Official title: A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on Tenofovir, Lamivudine, and Dolutegravir (TLD) in Sub-Saharan Africa
The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.
Read the detailed description
The RESOLVE trial is an open, parallel arm, randomized clinical trial which will be conducted at public-sector HIV clinics in Uganda and South Africa. We will enroll individuals with HIV age 15 and above who have had two HIV-1 RNA viral load results >1,000 copies/mL while on TLD and who have been on TLD for at least 12 months. Participants will be randomized using an equal allocation ratio of 1:1:1 across three study arms: a) Standard of Care (regimen guided by genotypic resistance tests and care as per guidelines in Uganda; and with regimen selection and possible genotypic resistance testing (GRT) and care as per guidelines in South Africa), 2) Individualized Care with regimen choice based on results of genotypic resistance tests and urine tenofovir adherence assays, or 3) Immediate Switch to PI-based second-line ART. Randomization will be stratified by clinic, prior exposure to non-nucleoside reverse transcriptase inhibitors, and virologic failure history. We will follow participants for one year with study visits at enrollment, Week 24, and Week 48. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition.
- Conditions
- HIV Infections, AIDS, Virologic Failure
- Being tested
- Standard of Care treatment strategy, Individualized Care treatment strategy, Immediate Switch
- Keywords
- ART, Medication Adherence, Drug resistance, Dolutegravir
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care treatment strategyOther
Management of virologic failure on TLD using the Standard of Care strategy
Individualized Care treatment strategyOther
Management of virologic failure on TLD using the Individualized Care strategy
Immediate SwitchOther
Management of virologic failure on TLD using the Immediate Switch strategy
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Experimental | In Uganda, participants will be managed per Ministry of Health (MOH) guidelines. GRT is performed by MOH for individuals with virologic failure on TLD. Participants will continue enhanced adherence counseling (EAC) and TLD while awaiting the GRT result. Treatment decision will be made by the regional switch committee when GRT results return. There will be a Week 24 visit for specimen collection.
In South Africa, participants will be managed per Department of Health (DOH) guidelines. Some individuals will be eligible for GRT (performed by DOH) based on ART duration and adherence per DOH guidelines. Treatment decision will be made by the clinic when GRT results return. Individuals who are ineligible for GRT will undergo EAC and continue on TLD. At Weeks 24, participants will undergo plasma HIV-1 RNA viral load testing. Results will be returned to the clinic team for patient management per DOH guidelines.
All participants undergo viral load testing at Week 48. Receives: Other: Standard of Care treatment strategy |
| Individualized Care | Experimental | Participants will undergo routine EAC, point-of-care urine tenofovir (TFV) testing, and genotypic resistance testing (GRT) at enrollment. Participants will return when GRT results are available for a treatment decision. Side effects and tolerance will also be assessed. All information will be used to make an optimal treatment recommendation with participant input. Participants will have an additional study visit at Week 24 and will continue to have routine care visits, adherence counseling by the clinic, and viral load monitoring at intervals determined by the clinic per national guidelines. Participants will undergo plasma HIV-1 RNA viral load testing at Week 48. Receives: Other: Individualized Care treatment strategy |
| Immediate Switch | Experimental | Participants will undergo routine EAC and a switch from TLD to PI-based second-line ART at the enrollment visit (Week 0). Participants will have an additional study visit at Week 24. Participants will continue to have routine care visits and viral load monitoring at intervals determined by the clinic per national guidelines. At study completion, participants will undergo plasma HIV-1 RNA viral load testing at Week 48. Receives: Other: Immediate Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression at 48 weeks
A plasma HIV-1 RNA viral load <50 copies/mL (FDA-snapshot definition)
Measured: 48 weeks post-enrollment (visit window spanning 42 to 54 weeks post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start7 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, University of KwaZulu, University of California, San Francisco, National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Suzanne McCluskey, Massachusetts General Hospital
- Investigators
- Suzanne McCluskey, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373758
- Sponsor's protocol ID
- 2022P001193
- Other IDs
- R01AI167699
- Acronym
- RESOLVE
- Status last verified
- Mar 2026
- First submitted
- 6 May 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on Tenofovir, Lamivudine, and Dolutegravir (TLD) in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT05373758
- Acronym / sponsor ID
- RESOLVE / 2022P001193
- Conditions
- HIV Infections, AIDS, Virologic Failure
- Keywords
- ART, Medication Adherence, Drug resistance, Dolutegravir
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, University of KwaZulu, University of California, San Francisco, National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 May 2022 (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.
The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.
Detailed description
The RESOLVE trial is an open, parallel arm, randomized clinical trial which will be conducted at public-sector HIV clinics in Uganda and South Africa. We will enroll individuals with HIV age 15 and above who have had two HIV-1 RNA viral load results >1,000 copies/mL while on TLD and who have been on TLD for at least 12 months. Participants will be randomized using an equal allocation ratio of 1:1:1 across three study arms: a) Standard of Care (regimen guided by genotypic resistance tests and care as per guidelines in Uganda; and with regimen selection and possible genotypic resistance testing (GRT) and care as per guidelines in South Africa), 2) Individualized Care with regimen choice based on results of genotypic resistance tests and urine tenofovir adherence assays, or 3) Immediate Switch to PI-based second-line ART. Randomization will be stratified by clinic, prior exposure to non-nucleoside reverse transcriptase inhibitors, and virologic failure history. We will follow participants for one year with study visits at enrollment, Week 24, and Week 48. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Experimental | Other: Standard of Care treatment strategyIn Uganda, participants will be managed per Ministry of Health (MOH) guidelines. GRT is performed by MOH for individuals with virologic failure on TLD. Participants will continue enhanced adherence counseling (EAC) and TLD while awaiting the GRT result. Treatment decision will be made by the regional switch committee when GRT results return. There will be a Week 24 visit for specimen collection. In South Africa, participants will be managed per Department of Health (DOH) guidelines. Some individuals will be eligible for GRT (performed by DOH) based on ART duration and adherence per DOH guidelines. Treatment decision will be made by the clinic when GRT results return. Individuals who are ineligible for GRT will undergo EAC and continue on TLD. At Weeks 24, participants will undergo plasma HIV-1 RNA viral load testing. Results will be returned to the clinic team for patient management per DOH guidelines. All participants undergo viral load testing at Week 48. |
| Individualized Care | Experimental | Other: Individualized Care treatment strategyParticipants will undergo routine EAC, point-of-care urine tenofovir (TFV) testing, and genotypic resistance testing (GRT) at enrollment. Participants will return when GRT results are available for a treatment decision. Side effects and tolerance will also be assessed. All information will be used to make an optimal treatment recommendation with participant input. Participants will have an additional study visit at Week 24 and will continue to have routine care visits, adherence counseling by the clinic, and viral load monitoring at intervals determined by the clinic per national guidelines. Participants will undergo plasma HIV-1 RNA viral load testing at Week 48. |
| Immediate Switch | Experimental | Other: Immediate SwitchParticipants will undergo routine EAC and a switch from TLD to PI-based second-line ART at the enrollment visit (Week 0). Participants will have an additional study visit at Week 24. Participants will continue to have routine care visits and viral load monitoring at intervals determined by the clinic per national guidelines. At study completion, participants will undergo plasma HIV-1 RNA viral load testing at Week 48. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 15 years and above
- Enrolled in HIV care at one of the study clinics
- History of two HIV-1 RNA viral load measurements >1,000 copies/mL while on TLD
- On TLD for at least 12 months
- Lives within 100 kilometers of study clinic
Key exclusion criteria (3 listed)
- Plans to transfer out of the clinic within the next 48 weeks
- Plans to move out of the study catchment area within the next 48 weeks
- As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.
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 |
|---|---|---|
| Standard of Care treatment strategyManagement of virologic failure on TLD using the Standard of Care strategy | Other | Standard of Care |
| Individualized Care treatment strategyManagement of virologic failure on TLD using the Individualized Care strategy | Other | Individualized Care |
| Immediate SwitchManagement of virologic failure on TLD using the Immediate Switch strategy | Other | Immediate Switch |
Primary outcome
Viral suppression at 48 weeks
Time frame: 48 weeks post-enrollment (visit window spanning 42 to 54 weeks post-enrollment)
A plasma HIV-1 RNA viral load <50 copies/mL (FDA-snapshot definition)
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 19 Mar 2026.
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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.
Suzanne McCluskey, MD principal investigator
Massachusetts General Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Care treatment strategy and Immediate Switch in people with HIV Infections and AIDS, run by Massachusetts General Hospital at 3 sites in 2 countries.
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 6 inclusion and 3 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 19 Mar 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 Uganda, 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.
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 Suzanne McCluskey, MD (617-726-9488, smccluskey@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression at 48 weeks (time frame: 48 weeks post-enrollment (visit window spanning 42 to 54 weeks post-enrollment)). 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 19 Mar 2026.