Kenya study tests simpler HIV drug switch for seniors
NCT ID NCT06444620
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether older adults (60+) living with HIV in Kenya can safely switch from their current three-drug pill to a simpler two-drug pill called DTG/3TC. About 240 participants who are already stable on treatment will be followed for 96 weeks. The main goal is to see if the new pill keeps the virus under control just as well.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DTG/3TC (dolutegravir and lamivudine combination pill)
- What this could lead to
- If successful, this could show that switching to a simpler two-drug pill is a safe and effective option for older adults living with HIV.
- What could go wrong
- This is a single-arm, open-label study with no comparison group, so results may be less reliable. It only includes people already stable on another treatment, so findings may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able and willing to understand and comply with the protocol requirements, instructions and restrictions * Able and willing to give informed consent * Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study. Participants should be on B/F/TAF until day 1 of entry into the current study * HIV-1 RNA viral load \< 50 copies/ml at screening (within 28 days prior to enrollment) Exclusion Criteria: * Confirmed treatment failure as defined by two consecutive HIV-1 RNA viral loads ≥ 50 copies/ml separated by at least 2 weeks, after at least 6 months on ART or after a documented HIV-1 RNA viral load \< 50 copies/ml * Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative (see Section 5.2. under Prohibited medications and non-drug therapies) * Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA as follows: 1. Participants positive for HBsAg are excluded; 2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded; 3. Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. * Has AST and/or ALT at least 5-times greater than the upper limit of normal * Severe hepatic impairment (Class C) as determined by Child-Pugh classification * Has an estimated creatinine clearance (CrCl) below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate) * Documented opportunistic infection within 4 weeks prior to the study enrolment * Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the study * Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible. * History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia. * Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk * Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Jaramogi Oginga Odinga Teaching and Referral Hospital
Kisumu, Kenya
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Kenyatta National Hospital
Nairobi, Kenya
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Other studies related to the condition(s) this trial covers.
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