HIV/AIDS
Conditions
Interventions
doravirine and islatravir
Placebo to bictegraviremtricitabine tenofoviralafenamide
bictegravir emtricitabinetenofovir alafenamide
Placebo to doravirineislatravir
Sponsors
MSD Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is HIV-1 positive with plasma HIV-1 RNA =500 copies/mL at screening. 2.Is naïve to ART defined as havingreceived no prior therapy with anyantiretroviral agent following adiagnosis of HIV-1 infection. 3. Is anindividual of any sex/gender, at least18 years of age, at the time ofproviding documented informedconsent. 4. A participant assignedfemale sex at birth is eligible toparticipate if not pregnant orbreastfeeding. 5. The participant (orlegally acceptable representative)has provided documented informedconsent for the study. Theparticipant may also provideconsent for FBR. However, theparticipant may participate in thestudy without participating in FBR.
Exclusion criteria
Exclusion criteria: 1. Has HIV-2 infection. 2. Hashypersensitivity or othercontraindication to any of thecomponents of the studyinterventions as determined by theinvestigator. 3.Has a diagnosis of anactive AIDS-defining opportunisticinfection within 30 days prior toscreening. 4. Has active HBVinfection (defined as HBsAg-positiveor HBV DNA-positive). 5. Haschronic HCV infection (detectableHCV RNA) with laboratory valuesconsistent with cirrhosis (serumalbumin 1.7 orplatelets <100 x 109 cells/L). 6. Hasa history of malignancy =5 yearsprior to providing documentedinformed consent except foradequately treated basal cell orsquamous cell skin cancer, in situcervical cancer, or cutaneousKaposi’s sarcoma. 7. Has a historyor current evidence of any condition(including active tuberculosisinfection), therapy, laboratoryabnormality, or other circumstance(including drug or alcohol use ordependence) that might, in theopinion of the investigator, confoundthe results of the study or interferewith the participant’s participation forthe full duration of the study, suchthat it is not in the best interest ofthe participant to participate. 8.Hasbeen treated for a viral infectionother than HIV-1, such as hepatitisB, with an agent that is activeagainst HIV-1, including, but notlimited to, the following: adefovir,TDF, TAF, FTC, or 3TC. 9.Is takingor is anticipated to require systemicimmunosuppressive therapy,immune modulators, or strong andmoderate CYP3A inducers (or anyother prohibited therapies outlined inSection 6.5) from 45 days prior toDay 1 through the study treatmentperiod. 10. Is currently participatingin or has participated in a clinicalstudy and received (or is receiving)an investigational compound ordevice from 45 days prior to Day 1through the study treatment period. 11. Has a documented or knownvirologic resistance to any approvedHIV-1 reverse transcriptase inhibitor,or any study intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of participants with HIV-1 RNA <50copies/mL 2.Percentage of participants whoexperience AEs and percentage of participants whodiscontinue study intervention due to AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with HIV-1 RNA <50copies/mL 2. Percentage of participants with HIV-1RNA <200 copies/mL at 3. Mean change frombaseline in CD4+ T-cell count 4. Viral resistance-associated substitutions 5. Mean change frombaseline in weight 6. General safety and tolerability | — |
Countries
Kenya, South Africa
Contacts
Public ContactZoe Nell
Clinical ResearchDirector
Outcome results
None listed