BridgeMD
Tests treatment safety and results for HIV-1-infection
Official title Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
ClinicalTrials.gov ID: NCT04892654
What this study is testing
What is Doravirine?
Doravirine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv-1-infection.
Also referred to as Pifeltro.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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...
- Concomitant medication contra-indicated with DTG or DOR
- Haemoglobin \<9 g/dL
- Platelets \<80,000/mm3
- Creatinine clearance \<30 mL/min
See the full eligibility criteria
- 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
- 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...
- Concomitant medication contra-indicated with DTG or DOR
- Haemoglobin \<9 g/dL
- Platelets \<80,000/mm3
- Creatinine clearance \<30 mL/min
- AST or ALT ≥5N
- Acute Hepatitis A infection.
- Concomitant DAA for anti-HCV therapy
- 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.
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.