An observational study in HIV-1-infection, sponsored by University of Nairobi. Active, not recruiting at 9 sites in 4 countries. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Nairobi · Observational
The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen. The study will also assess the emergence of DTG-associated drug-resistant mutations and their impact on viral suppression.
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 counseling. 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.
OBJECTIVE:
To assess viral suppression rate following enhanced adherence counseling among people on DTG-based ART who have sustained viraemia (≥ 1,000 copies/mL) after at least six months on ART.
METHODS:
This is a multi-country observational prospective cohort study over 12 months describing HIV-1 viral suppression in people with high viral load (≥ 1,000 copies/mL) after at least six months on DTG-based ART. The Study targets to enrol 6,600 participants in Kenya, Mozambique, Tanzania and Lesotho. Study visits and VL testing will take place at enrolment and then every 3 months for up to 12 months during the active follow-up period for participants who do not achieve viral suppression \< 200 copies/mL. During each visit, protocol-specified enhanced adherence counseling and assessment/management of other causes of viremia will continue for at least 3 sessions. For participants who achieve the primary outcome of HIV-1 RNA \< 200 copies/mL during the active follow-up period, a repeat VL will be performed after 3 months; outcomes from routinely collected program data (viral load, loss to follow-up, death) will be collected 12-24 months from enrolment to assess durability of suppression among this group. The investigators will estimate the viral suppression at 6 and 12 months using a generalized linear regression model with binomial distribution as well as assess for predictors of achieving suppression, development of DTG-associated drug resistance mutations (DRMs), and development of opportunistic infections using logistic regression models. Participants will also be assessed for eligibility to enrol into a nested randomized clinical trial (RCT) on management of people who develop DRMs during the cohort study (Ndovu RCT; see separate protocol).
University of Nairobi is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited without advertisement from the pool of patients receiving routine outpatient HIV care at the study sites and at surrounding HIV clinics in 8 central study sites in Kenya, 1 central study site in Tanzania (enrolling from surrounding care and treatment centres in Dar es Salaam), 6 study sites in Mozambique, and 5 study sites in Lesotho. The target sample size for this study is 6,600 participants. Participants who develop DTG-associated DRMs during cohort follow-up will be assessed for eligibility into a clinical trial assessing the optimal management of people who develop drug resistance to DTG-based ART (Ndovu RCT).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will continue on DTG-based ART after enrollment for up to 24 months
Participants with VL ≥200 copies/mL will undergo enhanced adherence counselling
Viral suppression rate
Viral suppression rate following enhanced adherence counseling
Time frame: 12 months
Time to viral suppression
Time to HIV-1 viral suppression to \< 200 copies/mL
Time frame: 24 months
Viral suppression by age strata
Viral load suppression rate by age strata: 1-9, 10-19, ≥20, 20-24, 25-34, 35-44, and ≥45 years old
Time frame: 24 months
Viral suppression by viral load strata
Viral load suppression by viral load strata: 1,000-99,999, and ≥100,000 copies/mL
Time frame: 24 months
Viral suppression by sex at birth
Viral load suppression based on participant's sex
Time frame: 24 months
Viral suppression by nucleoside/nucleotide reverse transcriptase inhibitor (NRTI)
Viral load suppression based on the NRTI component of the antiretroviral regimen
Time frame: 24 months
Durability of suppression
Durability of suppression at 3 months from first viral load of \<200 copies/mL
Time frame: 24 months
Incidence of drug resistant mutations (DRMs)
Incidence of treatment-emergent drug resistant mutations
Time frame: 24 months
Drug resistant mutations patterns
Drug resistant mutations (DRM) patterns (dolutegravir (DTG)-associated DRMs with or without concomitant nucleoside reverse transcriptase inhibitors drug resistant mutations) associated with sustained non-suppression or viral rebound after suppression
Time frame: 24 months
Predictors of development of dolutegravir (DTG)-associated drug resistant mutations
What are the predictors of development of dolutegravir (DTG)-associated drug resistant mutations
Time frame: 24 months
Time from viraemia to drug resistant mutations
Time from first detected viraemia to development of dolutegravir (DTG)-associated drug resistant mutations
Time frame: 24 months
Plan to share: Yes — The investigators will share the individual patient data (IPD) that underlie the results reported after de-identification (text, tables, figures and appendices)
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 6 months after publication of the final manuscript and for a period of 36 months
Access criteria: Access to IPD will be subject to the University of Nairobi data sharing requirements. Written requests should be submitted to the Principal Investigator providing a brief description of the individual or group making the request and detailing the reason for the same. Prior to sharing the data, the requestor will be required to sign a data access and sharing agreement.
Started Mar 2025 (actual). Primary completion is estimated for Feb 2027, 23 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Oct 2026 → Feb 2027 and completion Oct 2026 → Jan 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Nairobi