A Phase 3 interventional study of Doravirine and Dolutegravir in HIV-1-infection, sponsored by Chelsea and Westminster NHS Foundation Trust. Recruiting at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Chelsea and Westminster NHS Foundation Trust · Phase 3, Interventional, and Treatment
Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of cART can lead to side-effects through exposure to drug-related toxicity.
For this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV.
The purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.
A randomised, open label study to assess the efficacy of switching from suppressive triple cART to doravirine + dolutegravir dual cART in people living with HIV (PLWH) with an undetectable viral load
A computer-based software will randomise participants 2:1 to either the (1) experimental arm (early switch group) to take two-pill regimen for 96 weeks, or (2) control arm (delayed switch group) where participants continue their current triple cART regimen for 48 weeks, then switch to the two-pill regimen for another 48 weeks.
Viral load will be measured at each study visit to determine the percentage of participants in each treatment arm with undetectable plasma HIV RNA levels at week 48.
Additional research urine and bloods will be taken, as well as questionnaires completed at baseline and every 24 weeks to further investigate safety, tolerability, and quality of life from switch of suppressive triple cART to doravirine + dolutegravir dual cART.
Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Women who are pre-menopausal and sexually active should be on one of the following methods of :
Exclusion Criteria:
Known acute or chronic viral or C.
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 96 weeks.
Drug: Doravirine · Drug: Dolutegravir
Participants will continue their current triple cART regimen for 48 weeks. Patients will then be switched to two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 48 weeks.
Drug: Doravirine · Drug: Dolutegravir · Other: Triple cART regimen
Antiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor
Also known as: Pifeltro
Antiretroviral, Integrase strand transfer inhibitors
Also known as: Tivicay
Participant standard triple cART regimen
Percentage of Participants with undetectable plasma HIV RNA levels at Week 48
Undetectable will be defined as plasma HIV RNA levels of \<50 copies/ml. Any patient with HIV RNA levels \>50 copies/ml at analysis time points will have a repeat test
Time frame: 48 weeks from randomisation (+/- 7 days)
Proportion of patients treated on each treatment arm with HIV viral load less than 50 copies/ml to determine absolute efficacy of study treatments
Proportion of patients treated on each treatment arm with HIV viral load less than 50 copies/ml at weeks and 24, 72 and 96.
Time frame: 96 weeks from randomisation (+/- 7 days)
Frequency and severity of adverse events to determine safety and tolerability of study treatments
Occurrence of adverse events (including laboratory results), severity of adverse events and occurrence of treatment discontinuations measured through adverse event reporting by sites.
Time frame: 96 weeks from randomisation (+/- 7 days)
Changes in CD4 count and CD4:CD8 ratio to determine safety and tolerability of study treatments
CD4 count and CD4:CD8 ratio will be measured at screening and compared to measurements in both arms weeks 24, 48, 72 and 96
Time frame: 96 weeks from randomisation (+/- 7 days)
Scores from participant-recorded outcome measures on quality of life to determine safety and tolerability of study treatments
Scores from participant-recorded outcome measures at weeks 0, 24, 48, 72 and 96: EuroQoL EQ-5D-3L Questionnaire Score from 0 to 100 (with 100 as best outcome)
Time frame: 96 weeks from randomisation (+/- 7 days)
Scores from participant-recorded outcome measures on patient treatment satisfaction to determine safety and tolerability of study treatments
Scores from participant-recorded outcome measures at weeks 0, 24, 48, 72 and 96: Patient Treatment Satisfaction Questionnaire At week 0: Score from 0 to 6 (with 6 as best outcome) All other visits: Score -3 to +3 compared to week previous (with higher score best outcome)
Time frame: 96 weeks from randomisation (+/- 7 days)
Scores from participant-recorded outcome measures on sleep quality to determine safety and tolerability of study treatments
Scores from participant-recorded outcome measures at weeks 0, 24, 48, 72 and 96: Pittsburgh Sleep Quality Index (PSQI) Score range for each PSQI evaluation ranges from 0 to 21 (with 0 as best outcome)
Time frame: 96 weeks from randomisation (+/- 7 days)
Serum Neurofilament light chains (sNFL) comparison
NFL serum levels as measured at weeks 0, 48, 96.
Time frame: 96 weeks from randomisation (+/- 7 days)
Telomerase length comparison
Telomerase length measurements from samples taken at weeks 0, 48, 96.
Time frame: 96 weeks from randomisation (+/- 7 days)
Digit span tests comparison
Comparison of test results taken at weeks 0, 48, 96: • Digit span forward and backward nb - At Torino site only
Time frame: 96 weeks from randomisation (+/- 7 days)
Trail making tests comparison
Comparison of test results taken at weeks 0, 48, 96: • Trail making test A and B nb - At Torino site only
Time frame: 96 weeks from randomisation (+/- 7 days)
Verbal fluency tests comparison
Comparison of test results taken at weeks 0, 48, 96: • Phonemic verbal fluency nb - At Torino site only
Time frame: 96 weeks from randomisation (+/- 7 days)
Groove pegboard tests comparison
Comparison of test results taken at weeks 0, 48, 96: • Groove pegboard for dominant and non-dominant hand nb - At Torino site only
Time frame: 96 weeks from randomisation (+/- 7 days)
Bisyllabic words tests comparison
Comparison of test results taken at weeks 0, 48, 96: • Serial repetition of bisyllabic words test nb - At Torino site only
Time frame: 96 weeks from randomisation (+/- 7 days)
Metabolomics comparison
Comparison of liquid chromatography mass spectrometry (LC-MS) based metabolomics analysis on plasma and urine samples taken at weeks at week 0, 48, 96.
Time frame: 96 weeks from randomisation (+/- 7 days)
Started Aug 2022 (actual). Primary completion is estimated for Nov 2026, 51 months after the start.
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Studies of the drugs tested here: Doravirine · Dolutegravir
Chelsea and Westminster NHS Foundation Trust