NCT04892654RecruitingPhase 3
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (DORDOL)
Source: ClinicalTrials.gov · Last updated 25 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 11 Aug 2020
- Start date
- 17 Aug 2022
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Diseases
- HIV
- NCT number
- NCT04892654
- EU CT number
- 2023-509751-14-03
- EudraCT number
- 2020-003928-17
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From 17 Aug 2022 to the primary completion date, 30 Nov 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant medication contra-indicated with DTG or DOR
- Concomitant DAA for anti-HCV therapy
Other illness
- 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.
Lab values
- Haemoglobin \<9 g/dL
- Platelets \<80,000/mm3
- Creatinine clearance \<30 mL/min
- AST or ALT ≥5N
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mortimer Market Centre Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Chelsea & Westminster Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Azienda Sanitaria Locale Citta Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.