Health Trials

Investigating the Optimal Management of Dolutegravir Resistance

ConditionHIV-1-infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorUniversity of Nairobi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide informed consent (assent as appropriate and legal guardian consent if < 18 years)

Age ≥ 1 years

Documented HIV-1 infection as confirmed by national HIV testing standards at the respective study sites

On a DTG-based ART regimen for at least six months

Disqualifiers

Has switched ART regimen for confirmed or suspected HIV treatment failure while on a PI- or INSTI-based regimen

Any reason which, in the investigator's opinion, will significantly prevent the collection of viral load levels such as relocation to another area outside of the trial sites or imminent death

Concomitant NNRTI or PI while on DTG

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Continue DTG-based antiretroviral therapy

    Drug

    Participants will continue on DTG-based ART after enrollment for up to 12 months

  • Enhanced adherence counselling

    Behavioral

    Participants with VL ≥200 copies/mL will undergo enhanced adherence counselling

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Viral suppression rate

Viral suppression rate following enhanced adherence counseling

Time frame
12 months

Secondary outcomes

1

Time to viral suppression

Time to HIV-1 viral suppression to \< 200 copies/mL

Time frame
12 months
2

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
12 months
3

Viral suppression by viral load strata

Viral load suppression by viral load strata: 1,000-99,999, and ≥100,000 copies/mL

Time frame
12 months
4

Viral suppression by sex at birth

Viral load suppression based on participant's sex

Time frame
12 months

Other outcomes

Sponsors and contacts

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University of Nairobi

Lead sponsor

Instituto Nacional de Saúde, Mozambique

Collaborator

Muhimbili University of Health and Allied Sciences

Collaborator

SolidarMed

Collaborator

London School of Hygiene and Tropical Medicine

Collaborator

Source ClinicalTrials.gov
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