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New treatment option for HIV Infections
Official title HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label
ClinicalTrials.gov ID: NCT04513626
What this study is testing
What is DORAVIRINE 100 MG [Pifeltro]?
DORAVIRINE 100 MG [Pifeltro] is an investigational medicine, given as an once-daily, being studied as a potential treatment for hiv infections.
Also referred to as Raltegravir 600 Mg x 2 [Isentress].
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
- The objective of antiretroviral therapy (ART) is the maintenance of HIV viral suppression, the optimal condition to prevent disease progression, to optimize immune restoration, to prevent the development of viral resistance and to reduce viral transmission. Antiretroviral therapy has to be maintained long life over decades in the absence of strategies for HIV cure.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 96 weeks
- 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
- Age ≥ 18 years
- Patients with HIV-1 documented infection
- CD4 ≥ 200/mm3
- On stable combined ART regimen with at least 2 drugs for at least 6 months
- HIV-RNA plasma VL ≤ 50 copies/mL during the last 12 months prior to screening visit (W-6/W-4), documented by at least 2 time-points with no more than...
You likely can't join if
- Absence of RT and INI HIV sequence available (past genotypes or failure of amplification of DNA at screening)
- HBV co-infection
- Hemoglobin \<9 g/dL
- Platelets \<80,000/mm3
- Creatinine clearance \<60 mL/min (MDRD)
- AST or ALT ≥5N
See the full eligibility criteria
- Age ≥ 18 years
- Patients with HIV-1 documented infection
- CD4 ≥ 200/mm3
- On stable combined ART regimen with at least 2 drugs for at least 6 months
- HIV-RNA plasma VL ≤ 50 copies/mL during the last 12 months prior to screening visit (W-6/W-4), documented by at least 2 time-points with no more than one blip (defined as one HIV-RNA plasma VL between 51 and 200...
- Naive to doravirine
- Absence of resistance to doravirine\ and/or raltegravir\ \ (see list mutations below)
- on all HIV-genotypes with available RT and integrase gene sequences allowing resistance interpretation in case of previous virological failure
- or on DNA genotype performed at screening if HIV genotype is not available in case of prior virological failure.
- Signed informed consent form.
- Patient affiliated to a social insurance regimen. For French patients only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme).
- Mutations associated to doravirine resistance are: V106A/M, Y188L, G190E/S, M230L, F227C, at least 2 among: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
- Mutations associated to raltegravir resistance are: T66A/K, E92Q, G118R, F121Y, G140A/S Y143A/C/G/H/R/S, Q148E/G/H/K/R, V151L, N155H/S/T, E157Q, S230R, R263K, L74 F/I + V75I.
- Absence of RT and INI HIV sequence available (past genotypes or failure of amplification of DNA at screening)
- HBV co-infection
- Hemoglobin \<9 g/dL
- Platelets \<80,000/mm3
- Creatinine clearance \<60 mL/min (MDRD)
- AST or ALT ≥5N
- Concomitant DAA for anti-HCV therapy
- Any severe concomitant illness
- Any drug with potential drug-drug interaction with doravirine
- Concomitant treatment using interferon, interleukins or any other immune-therapy or chemotherapy
- Concomitant prophylactic or curative treatment for an opportunistic infection
- All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
- people under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
- people participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase
- Pregnant women or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
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 study runs about 96 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Paris, Île-de-France Region, France. 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.