Tests doravirine and dolutegravir as HIV treatment after switching medicines
Tests two HIV medicines together in adults already on HIV treatment.
Plain-language title generated from the registry record
Registry title: Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
Key facts
- Where
- Turin, ItalySee the site
- Phase
- Phase 3
Where in Italy
- Azienda Sanitaria Locale Citta Di TorinoTurin, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chelsea and Westminster NHS Foundation Trust
- Trial code
- NCT04892654EU 2023-509751-14-03
- Record updated
- 25 October 2023
- Original description
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.Read full original descriptionShow less
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (DORDOL)
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.
Inclusion: HIV-1 infected, 18 years or older; On stable \& suppressive triple cART for at least 6 months; No evidence of resistance to DOR or DTG; No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators; Women who are pre-menopausal and sexually active should be on one of the following methods of contraception:; Implant; Depot injection; Intra-uterine device or system; Oral hormonal contraception.
Exclusion: Concomitant medication contra-indicated with DTG or DOR; Concomitant DAA for anti-HCV therapy; History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR; History of virological failure on an INSTI in absence of a post-failure genotypic resistance test proving absence of resistance to DTG (INSTI mutations that will lead to the need of administering DTG twice-daily are considered as resistance to DTG - and the subject will be considered NOT eligible); Acute Hepatitis A infection; Known acute or chronic viral hepatitis B or C; Individuals testing positive for HBcAb, but negative HBsAg/HBeAg, may be included on the trial; Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial; Haemoglobin <9 g/dL; Platelets <80,000/mm3; Creatinine clearance <30 mL/min; AST or ALT ≥5N; Pregnant or breastfeeding women.