HIV-1-infectionPhase 3NCT06747507
Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
A Phase 3 study testing Dolutegravir Pill and Darunavir+Ritonavir in people with HIV-1-infection, run by University of Nairobi at 9 sites in 4 countries.
Trial summary
This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Dolutegravir Pill and Darunavir+Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 1 Sep 2025to Jul 2027
- Phase
- Phase 3
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrolled in the Ndovu cohort study
- Able and willing to understand and comply with the protocol requirements, instructions and restrictions
- Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if < 18 years)
- Age ≥ 3 years
- Most recent HIV-1 RNA ≥ 200 copies/mL
- At least one major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K/A/T, 140S/A/C, 148H/R/K, 155H or 263K)
Who cannot join
- Pregnant or breastfeeding
- Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs
- WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening
- Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons
- Investigator opinion that the potential participant should not switch to DRV/r for clinical reasons
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 4 countries
Kenya3 sites, 3 recruiting
- Recruiting
Jaramogi Oginga Odinga Teaching and Referral Hospital
Kisumu
Joseph Nkuranga, +254737223988, dnkuranga@uonbi.ac.ke
- Not yet recruiting
Bomu Hospital
Mombasa
Nashina Admani
- Recruiting
Kenyatta National Hospital
Nairobi, 00100
Joseph Nkuranga, +254737223988, dnkuranga@uonbi.ac.ke
Mozambique3 sites, 3 recruiting
- Not yet recruiting
CS Ponta Gea
Beira, Sofala
Nalia Ismael
- Not yet recruiting
CS Machava II
Maputo
Nalia Ismael
- Not yet recruiting
CS Ndlavela
Maputo
Nalia Ismael
Lesotho2 sites, 2 recruiting
- Not yet recruiting
Butha-Buthe District Hospital
Butha-Buthe
Irene Ayakaka
- Not yet recruiting
Mokhotlong District Hospital
Mokhotlong
Irene Ayakaka
Tanzania1 site, 1 recruiting
- Not yet recruiting
MUHAS Clinical Trial Unit
Dar es Salaam
Patricia Munseri
About this study
Official title: Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir
This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.
Read the detailed description
BACKGROUND:
The majority of people living with HIV (PLWH) on first-line antiretroviral therapy (ART) in low- and middle-income countries are on dolutegravir (DTG)-containing regimens. Different countries have adopted different approaches in the management of people on DTG-based first-line ART with repeat HIV viral load (VL) of > 1,000 copies/mL after 3 months of enhanced adherence counselling. For example, Kenya recommends a drug resistance test (DRT) to guide on switch and the optimal second-line regimen; Mozambique and Tanzania recommend switch to 2 nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors (PIs) without drug resistance testing; South Africa does not recommend switch from DTG or DRT for those who are on first-line DTG-containing regimens within the first 2 years of treatment, after which management is guided by possible DRT and expert opinion. The World Health Organization has recognised the role of drug resistance testing (DRT) in a treatment failure algorithm for people living with HIV receiving DTG-based treatment to minimise unnecessary switches from this regimen. The switch to PI has disadvantages including higher cost, higher pill burden, less convenient administration (often should be taken with food), more potential drug-drug interactions, poorer tolerability and more long-term toxicities.
GOAL:
To assess the efficacy and safety of remaining on DTG compared to switching to DRV/r among people failing DTG-based ART with at least one major DTG DRM.
METHODS:
This is a phase 3b, multi-country, open-label, two-arm, active-controlled randomized clinical trial (RCT) over 12 months describing the efficacy and safety of switching from DTG to DRV/r among PLWH age ≥ 3 years who are failing DTG-based ART with HIV-1 RNA ≥ 200 copies/mL and ≥ 1 major DTG-associated DRM (and most recent prior HIV-1 RNA ≥ 1,000 copies/mL after at least 6 months on DTG-based ART). The primary efficacy endpoint is the proportion of participants with HIV-1 RNA < 200 copies/mL at month 6. The study will be conducted in 9 sites in Kenya, Mozambique, Tanzania and Lesotho targeting 392 participants including 30 children aged between 3 and 14 years old. The primary efficacy analysis will assess the difference in the proportion of participants with viral suppression at month 6 using the Cochran-Mantel-Haenszel method. This RCT is nested within an observational cohort study describing HIV-1 viral suppression of people with HIV-1 RNA value of ≥ 1,000 copies/mL after at least six months on DTG-based ART.
- Conditions
- HIV-1-infection
- Being tested
- Dolutegravir Pill, Darunavir+Ritonavir
- Keywords
- HIV, Dolutegravir, Treatment failure, Drug resistant mutations, Dolutegravir resistance, Re-suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir PillDrug
Dose will be based on weight; brand names will be as supplied through the respective national programs
Darunavir+RitonavirDrug
Also called Durart
Dose will be based on weight
| Study group | Role | What they receive |
|---|---|---|
| Continue on DTG-based Therapy | Experimental | Participants in this arm will continue their pre-randomization DTG-based ART regimen Receives: Drug: Dolutegravir Pill |
| Switch to PI-based Therapy | Active comparator | Participants in this arm will be switched to ritonavir-boosted darunavir (DRV/r)-based ART regimen on the day of randomization Receives: Drug: Darunavir+Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with HIV-1 RNA of <200 copies/mL at 6 months
The comparative efficacy of switching to a DRV/r-based regimen after confirmed virologic failure and of remaining on DTG-based ART in achieving viral suppression of <200 copies/mL at 6 months from randomization among participants with ≥1 major DTG-associated DRM
Measured: 6 months
Secondary outcomes (17)
Proportion of participants with HIV-1 RNA of <200 copies/mL at 12 months
Viral suppression to HIV-RNA of <200 copies/mL at 12 months from randomization
Measured: 12 months
Superiority of switch to DRV/r
Evaluate if switching to DRV/r-based ART after virologic failure is superior to remaining on DTG-based ART in achieving viral suppression to <200 copies/mL at 6 months from randomization
Measured: 6 months
Viral suppression with cut-off of 50 copies/mL
Evaluate the difference in viral suppression using HIV-RNA cut-off of <50 copies/mL at 6 and 12 months from randomization
Measured: 6 and 12 months
Viral suppression with cut-off of 1,000 copies/mL
Evaluate the difference in viral suppression using HIV-RNA cut-off of <1,000 copies/mL at 6 and 12 months from randomization
Measured: 6 and 12 months
Viral suppression by age strata
Viral load suppression rate by age strata: 3-9, 10-19, ≥20, 20-24, 25-34, 35-44, and ≥45 years old
Measured: 6 and 12 months
Viral suppression by sex at birth
Viral load suppression based on participant's sex
Measured: 6 and 12 months
Incidence of adverse events by study arm
Incidence and severity of adverse events and laboratory abnormalities
Measured: 6 and 12 months
Association between adherence and suppression
Adherence levels, based on DBS TFV-DP levels, associated with suppression and selection of treatment-emergent DRMs
Measured: 6 months
Incidence of drug resistant mutations (DRMs)
Incidence of treatment-emergent DRMs over 12 months of follow-up
Measured: 6 and 12 months
Patterns of accumulated drug resistant mutations (DRMs)
Describe the patterns of accumulated drug resistant mutations over 12 months of follow-up
Measured: 6 and 12 months
Drug resistant mutations (DRM) patterns associated with non-suppression
Evaluate drug resistant mutation patterns that are associated with sustained non-suppression
Measured: 6 and 12 months
Predictors of DTG-associated drug resistant mutations (DRMs)
Investigate the predictors of selection of DTG-associated drug resistant mutations
Measured: 6 and 12 months
Viral suppression by pre-enrolment nucleoside reverse transcriptase inhibitor (NRTI)
Assess viral suppression based on pre-enrolment NRTI
Measured: 6 and 12 months
Viral suppression by tenofovir disoproxil fumarate versus tenofovir alafenamide
Assess viral suppression based on tenofovir disoproxil fumarate (TDF) versus tenofovir alafenamide (TAF) as the study nucleoside reverse transcriptase inhibitor
Measured: 6 and 12 months
Change in cluster of differentiation 4 (CD4) Count
The impact of regimen on change in cluster of differentiation 4 (CD4) count
Measured: 6 and 12 months
Patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Status version (HIVTSQs) which scores 10 variables on a 7-point likert score ranging from 0 to 6 with a higher score representing a better outcome
Patient satisfaction (HIVTSQs) at baseline
Measured: 6 months
Change in patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Change version (HIVTSQc) which scores 10 variables on a 7-point likert score ranging from -3 to +3 with a higher score representing a better outcome
Patient satisfaction (HIVTSQc) at month 6
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 3b, multi-country, open-label, two-arm, active-controlled randomized clinical trial over 12 months describing the efficacy and safety of switching from DTG to DRV/r among PLWH age ≥ 3 years who are failing DTG-based ART with HIV-1 RNA ≥ 200 copies/mL and ≥ 1 major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K/A/T, 140S/A/C, 148H/R/K, 155H or 263K ), and most recent prior HIV-1 RNA ≥1,000 copies/mL after at least 6 months on DTG-based ART.
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nairobi
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Saúde, Mozambique, Muhimbili University of Health and Allied Sciences, SolidarMed, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Loice Achieng Ombajo, University of Nairobi
- Investigators
- Loice A Ombajo, MMed, MSc, Principal investigator, University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747507
- Sponsor's protocol ID
- Ndovu RCT
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share the individual patient data (IPD) that underlie the results reported after de-identification (text, tables, figures and appendices).
Publications
Ombajo LA, Nkuranga J, Penner J, Kamau EW, Ismael N, Munseri P, Ayakaka I, Labhardt N, Wamalwa D, Ramgi P, Chissumba RM, Wagude J, Bakari M, Omodi V, Otieno E, Abuogi L, Patel R, Opondo C, Grint D, King'wara L, Macharia A, Mulwa A, Amoth P; Ndovu study group. The dolutegravir failure cohort: A multi-country longitudinal cohort with a randomised clinical trial of continued dolutegravir versus switch to darunavir in people with viraemia while on dolutegravir in Sub-Saharan Africa (The Ndovu Study) protocol. PLoS One. 2026 Mar 13;21(3):e0330792. doi: 10.1371/journal.pone.0330792. eCollection 2026.
PubMed 41824511
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir
- ClinicalTrials.gov ID
- NCT06747507
- Acronym / sponsor ID
- Ndovu RCT
- Conditions
- HIV-1-infection
- Keywords
- HIV, Dolutegravir, Treatment failure, Drug resistant mutations, Dolutegravir resistance, Re-suppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- University of NairobiUniversity, hospital or other
- Collaborators
- Instituto Nacional de Saúde, Mozambique, Muhimbili University of Health and Allied Sciences, SolidarMed, London School of Hygiene and Tropical Medicine
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Dec 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 clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.
Detailed description
BACKGROUND:
The majority of people living with HIV (PLWH) on first-line antiretroviral therapy (ART) in low- and middle-income countries are on dolutegravir (DTG)-containing regimens. Different countries have adopted different approaches in the management of people on DTG-based first-line ART with repeat HIV viral load (VL) of > 1,000 copies/mL after 3 months of enhanced adherence counselling. For example, Kenya recommends a drug resistance test (DRT) to guide on switch and the optimal second-line regimen; Mozambique and Tanzania recommend switch to 2 nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors (PIs) without drug resistance testing; South Africa does not recommend switch from DTG or DRT for those who are on first-line DTG-containing regimens within the first 2 years of treatment, after which management is guided by possible DRT and expert opinion. The World Health Organization has recognised the role of drug resistance testing (DRT) in a treatment failure algorithm for people living with HIV receiving DTG-based treatment to minimise unnecessary switches from this regimen. The switch to PI has disadvantages including higher cost, higher pill burden, less convenient administration (often should be taken with food), more potential drug-drug interactions, poorer tolerability and more long-term toxicities.
GOAL:
To assess the efficacy and safety of remaining on DTG compared to switching to DRV/r among people failing DTG-based ART with at least one major DTG DRM.
METHODS:
This is a phase 3b, multi-country, open-label, two-arm, active-controlled randomized clinical trial (RCT) over 12 months describing the efficacy and safety of switching from DTG to DRV/r among PLWH age ≥ 3 years who are failing DTG-based ART with HIV-1 RNA ≥ 200 copies/mL and ≥ 1 major DTG-associated DRM (and most recent prior HIV-1 RNA ≥ 1,000 copies/mL after at least 6 months on DTG-based ART). The primary efficacy endpoint is the proportion of participants with HIV-1 RNA < 200 copies/mL at month 6. The study will be conducted in 9 sites in Kenya, Mozambique, Tanzania and Lesotho targeting 392 participants including 30 children aged between 3 and 14 years old. The primary efficacy analysis will assess the difference in the proportion of participants with viral suppression at month 6 using the Cochran-Mantel-Haenszel method. This RCT is nested within an observational cohort study describing HIV-1 viral suppression of people with HIV-1 RNA value of ≥ 1,000 copies/mL after at least six months on DTG-based ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase 3b, multi-country, open-label, two-arm, active-controlled randomized clinical trial over 12 months describing the efficacy and safety of switching from DTG to DRV/r among PLWH age ≥ 3 years who are failing DTG-based ART with HIV-1 RNA ≥ 200 copies/mL and ≥ 1 major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K/A/T, 140S/A/C, 148H/R/K, 155H or 263K ), and most recent prior HIV-1 RNA ≥1,000 copies/mL after at least 6 months on DTG-based ART.
| Arm | Type | Receives |
|---|---|---|
| Continue on DTG-based Therapy | Experimental | Drug: Dolutegravir PillParticipants in this arm will continue their pre-randomization DTG-based ART regimen |
| Switch to PI-based Therapy | Active comparator | Drug: Darunavir+RitonavirParticipants in this arm will be switched to ritonavir-boosted darunavir (DRV/r)-based ART regimen on the day of randomization |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Enrolled in the Ndovu cohort study
- Able and willing to understand and comply with the protocol requirements, instructions and restrictions
- Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if < 18 years)
- Age ≥ 3 years
- Most recent HIV-1 RNA ≥ 200 copies/mL
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding
- Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs
- WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening
- Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons
- Investigator opinion that the potential participant should not switch to DRV/r for clinical reasons
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 |
|---|---|---|
| Dolutegravir PillDose will be based on weight; brand names will be as supplied through the respective national programs | Drug | Continue on DTG-based Therapy |
| Darunavir+RitonavirAlso: DurartDose will be based on weight | Drug | Switch to PI-based Therapy |
Primary outcome
Proportion of participants with HIV-1 RNA of <200 copies/mL at 6 months
Time frame: 6 months
The comparative efficacy of switching to a DRV/r-based regimen after confirmed virologic failure and of remaining on DTG-based ART in achieving viral suppression of <200 copies/mL at 6 months from randomization among participants with ≥1 major DTG-associated DRM
17 secondary outcomes
Proportion of participants with HIV-1 RNA of <200 copies/mL at 12 months
Time frame: 12 months
Superiority of switch to DRV/r
Time frame: 6 months
Viral suppression with cut-off of 50 copies/mL
Time frame: 6 and 12 months
Viral suppression with cut-off of 1,000 copies/mL
Time frame: 6 and 12 months
Viral suppression by age strata
Time frame: 6 and 12 months
Viral suppression by sex at birth
Time frame: 6 and 12 months
Incidence of adverse events by study arm
Time frame: 6 and 12 months
Association between adherence and suppression
Time frame: 6 months
Incidence of drug resistant mutations (DRMs)
Time frame: 6 and 12 months
Patterns of accumulated drug resistant mutations (DRMs)
Time frame: 6 and 12 months
Drug resistant mutations (DRM) patterns associated with non-suppression
Time frame: 6 and 12 months
Predictors of DTG-associated drug resistant mutations (DRMs)
Time frame: 6 and 12 months
Viral suppression by pre-enrolment nucleoside reverse transcriptase inhibitor (NRTI)
Time frame: 6 and 12 months
Viral suppression by tenofovir disoproxil fumarate versus tenofovir alafenamide
Time frame: 6 and 12 months
Change in cluster of differentiation 4 (CD4) Count
Time frame: 6 and 12 months
Patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Status version (HIVTSQs) which scores 10 variables on a 7-point likert score ranging from 0 to 6 with a higher score representing a better outcome
Time frame: 6 months
Change in patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Change version (HIVTSQc) which scores 10 variables on a 7-point likert score ranging from -3 to +3 with a higher score representing a better outcome
Time frame: Month 6
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 11 Sep 2025.
- Derived from this study: PubMed 41824511Ombajo LA, Nkuranga J, Penner J, Kamau EW, Ismael N, Munseri P, Ayakaka I, Labhardt N, Wamalwa D, Ramgi P, Chissumba RM, Wagude J, Bakari M, Omodi V, Otieno E, Abuogi L, Patel R, Opondo C, Grint D, King'wara L, Macharia A, Mulwa A, Amoth P; Ndovu study group. The dolutegravir failure cohort: A multi-country longitudinal cohort with a randomised clinical trial of continued dolutegravir versus switch to darunavir in people with viraemia while on dolutegravir in Sub-Saharan Africa (The Ndovu Study) protocol. PLoS One. 2026 Mar 13;21(3):e0330792. doi: 10.1371/journal.pone.0330792. eCollection 2026.
- Individual participant dataSharing planned: Yes. The investigators will share the individual patient data (IPD) that underlie the results reported after de-identification (text, tables, figures and appendices).
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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.
Loice A Ombajo, MMed, MSc principal investigator
University of Nairobi
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dolutegravir Pill and Darunavir+Ritonavir in people with HIV-1-infection, run by University of Nairobi at 9 sites in 4 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 5 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Kenya, Mozambique, Lesotho, Tanzania. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Joseph Nkuranga, MBChB, MSc (+254737223988, dnkuranga@uonbi.ac.ke), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with HIV-1 RNA of <200 copies/mL at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747507, which also lists 1 linked publication.
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 11 Sep 2025.