HIV InfectionsPhase 2DORALNCT04513626
HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label
A Phase 2 study testing DORAVIRINE 100 MG [Pifeltro] in people with HIV Infections, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- DORAVIRINE 100 MG [Pifeltro]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2020to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 copies/mL followed by one HIV-RNA plasma VL ≤ 50 copies/mL)
- Naive to doravirine
Show all 13Show fewer
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
- Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
- Subjects 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Christine KATLAMA
Paris, Île-de-France Region, 75013
Yasmine Dudoit, 33142164181, yasmine.dudoit@aphp.fr
Christine Katlama, MD, 33142160142, christine.katlama@aphp.fr
About this study
Official title: A Randomized Comparative Phase II Trial Evaluating the Capacity of the Dual Combination Doravirine/Raltegravir to Maintain Virological Success in HIV-1 Infected Patients With an HIV-RNA Plasma Viremia Below 50 Copies/mL Under a Current Antiretroviral Regimen
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. This is why the long-term cumulative toxicity of ARV drugs is a major issue. Indeed as a consequence of potent ART strategies, in 2011 over 88% of patients on ART in the French Hospital database (ANRS CO4 FHDH) achieved viral suppression with HIV-RNA plasma viral load < 50 copies/mL and nearly 60% had CD4 > 500/mm3. As a consequence of massive reduction of mortality and morbidity related to HIV, infected patients are aging with 40% of patients over 50 years of age in the ANRS CO4 FHDH.
The current standard-of-care for antiretroviral therapy consists in a triple drug combination with two nucleoside reverse transcriptase inhibitors (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), a protease inhibitor (PI), or an integrase inhibitor (INSTI). NRTIs and PIs have been associated to cumulative long-term toxicity such as bone and renal disorders related to tenofovir and increased cardio-vascular risk with PIs. In general population, aging is associated with well-known comorbidities such as bone demineralization, increased incidence of cardio or cerebrovascular disease, diabetes, renal dysfunction. HIV infected patients are at a greater risk for such abnormalities. Another crucial concern is the high probability of drug-drug interactions in HIV-infected patients, between ART and comedications.
Read more
Alternative strategies are needed, which must address the following questions: how to maintain the control of HIV viral replication while minimizing the occurrence of long-term clinical and metabolic complications, and minimizing the risk of drug-drug interactions?
This study is an open label, randomized, switch study over 96 weeks in which virally suppressed patients on a stable combined ART regimen will be randomized (2:1) to an immediate switch to doravirine/raltegravir (immediate switch group) or to the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). Patients will be followed during 96 weeks.
Read the detailed description
The recent years have highlighted the cumulative toxicities of long-term exposure to antiretroviral drugs. Cardiovascular disease is one of the most common comorbidities in the aging HIV-infected population. Coronary artery disease (CAD) results from a combination of increasing age, traditional risk factor such as smoking, toxicity from long-term ART, and potentially related to HIV immune activation.
Most of boosted PIs and the NNRTI [efavirenz] are associated to an increase in triglycerides and total cholesterol plasma levels. In the ANRS CO8 APROCO COPILOTE cohort about 30% of patients developed hypertriglyceridemia. Prevalence of lipodystrophy and metabolic alterations and these alterations appear as early as 12 months after the initiation of PI therapy.
The prevalence of osteopenia and osteoporosis in HIV-infected individuals is higher in HIV-infected compared with HIV-negative individuals ranging, from 23 to 65% for osteopenia and from 3 to 22% for osteoporosis according to the studies [13-16] with, as consequence, a higher prevalence of patients with fracture (p < 0.0001).
Tenofovir is currently the most widely used antiretroviral drug. Globally, clinical trials have suggested that renal toxicity related to tenofovir is low (approximately 1%) in selected populations from clinical studies. However, observational cohort studies have suggested that this risk was higher with rates varying from approximately 2%.
In a systematic review and meta-analysis whereas over time with longer exposure to antiretroviral drugs the overall relative risk of renal disease was 3.87 (95% CI: 2.85-6.85) in HIV-infected patients compared to HIV-uninfected in ART treated patients. 0.54 (95% CI: 0.29-0.99) compared to naïve patients and 1.56 (95% CI: 0.83-2.93) in patients treated with tenofovir compared to patients without tenofovir.
In the DAD study not only tenofovir but also abacavir, lopinavir/ritonavir and atazanavir/ritonavir were associated to high risk.
The use of strategies that could minimize renal toxicity has to be investigated particularly in senior HIV infected population.
Increased risk for drug-drug interactions: a cause of concern in the elderly. Aging increases polypharmacy prescriptions for treatment and prevention of comorbidities such as cardio-vascular disease, hypertension or diabetes. One major issue is the risk for drug-drug interactions in elderly ART treated HIV infected patients due to the common CYP450 cytochrome pathway, shared by ARV drug and drug for comorbidities.
Monitoring concentration of these drugs is not easy in routine practice. Given these drug-drug interactions with potential severe clinical consequences, it is key to investigate alternative ART strategies with different metabolization pathways, such as raltegravir.
Raltegravir and Doravirine: benefits and advantages in terms of toxicity. Overall, literature data showed that raltegravir and doravirine are two drugs with high antiretroviral potency, including in experienced HIV-treated patients, with very good tolerance profile and without expected drug-drug interaction between the two drugs. A new dual therapy strategy combining doravirine + raltegravir given once daily has to be evaluated.
In the setting of dual therapies, and as background the excellent results in terms of efficacy of doravirine plus raltegravir (<2% of virological failure (95% confidence interval 0.3 to 5.0) at week 96 of 165 participants in the ETRAL), we postulate that:
- The association of raltegravir 1200 mg QD and doravirine 100 mg QD (DOR/RAL) will maintain viral suppression in HIV-1-infected patients with suppressed viremia on ART, with a virological failure rate of <12% in a population of 100 patients
- DOR/RAL will be associated to a robust viral suppression with limited amount of blips
- DOR/RAL will be well tolerated over the study period
- Acquired resistance to doravirine or raltegravir will be limited in case of virological failure
- DOR/RAL will present a benefit for patients on metabolic parameters and general symptoms
- Conditions
- HIV Infections
- Being tested
- DORAVIRINE 100 MG [Pifeltro]
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DORAVIRINE 100 MG [Pifeltro]Drug
Also called Raltegravir 600 Mg x 2 [Isentress]
Immediate switch
| Study group | Role | What they receive |
|---|---|---|
| Delayed switch | Other | the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). Receives: Drug: DORAVIRINE 100 MG [Pifeltro] |
| Immediate switch | Experimental | Immediate switch to doravirine/raltegravir Receives: Drug: DORAVIRINE 100 MG [Pifeltro] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the virological efficacy at week 48 of once daily doravirine plus raltegravir dual therapy to assess the effectiveness of the dual therapy DORAL to maintain the virological success to W48
Measure of plasma viral load assessed by RNA quantification using COBA 6800 system (Roche)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start15 Sep 2020
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study is an open label, randomized, switch study, over 96 weeks, in which virally suppressed patients on a stable combined ART regimen will be randomized (2:1) to an immediate switch to doravirine/raltegravir (immediate switch group) or to the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). Patients will be followed during 96 weeks. The randomization will be stratified on gender and antiretroviral regimen at inclusion (Dual therapy or more).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Katlama, MD, Principal investigator, Pitie-Salpetriere Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513626
- Sponsor's protocol ID
- CREPATS 010
- Acronym
- DORAL
- Status last verified
- Jan 2025
- First submitted
- 12 Aug 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Phase II Trial Evaluating the Capacity of the Dual Combination Doravirine/Raltegravir to Maintain Virological Success in HIV-1 Infected Patients With an HIV-RNA Plasma Viremia Below 50 Copies/mL Under a Current Antiretroviral Regimen
- ClinicalTrials.gov ID
- NCT04513626
- Acronym / sponsor ID
- DORAL / CREPATS 010
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This is why the long-term cumulative toxicity of ARV drugs is a major issue. Indeed as a consequence of potent ART strategies, in 2011 over 88% of patients on ART in the French Hospital database (ANRS CO4 FHDH) achieved viral suppression with HIV-RNA plasma viral load < 50 copies/mL and nearly 60% had CD4 > 500/mm3. As a consequence of massive reduction of mortality and morbidity related to HIV, infected patients are aging with 40% of patients over 50 years of age in the ANRS CO4 FHDH.
The current standard-of-care for antiretroviral therapy consists in a triple drug combination with two nucleoside reverse transcriptase inhibitors (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), a protease inhibitor (PI), or an integrase inhibitor (INSTI). NRTIs and PIs have been associated to cumulative long-term toxicity such as bone and renal disorders related to tenofovir and increased cardio-vascular risk with PIs. In general population, aging is associated with well-known comorbidities such as bone demineralization, increased incidence of cardio or cerebrovascular disease, diabetes, renal dysfunction. HIV infected patients are at a greater risk for such abnormalities. Another crucial concern is the high probability of drug-drug interactions in HIV-infected patients, between ART and comedications.
Alternative strategies are needed, which must address the following questions: how to maintain the control of HIV viral replication while minimizing the occurrence of long-term clinical and metabolic complications, and minimizing the risk of drug-drug interactions?
This study is an open label, randomized, switch study over 96 weeks in which virally suppressed patients on a stable combined ART regimen will be randomized (2:1) to an immediate switch to doravirine/raltegravir (immediate switch group) or to the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). Patients will be followed during 96 weeks.
Detailed description
The recent years have highlighted the cumulative toxicities of long-term exposure to antiretroviral drugs. Cardiovascular disease is one of the most common comorbidities in the aging HIV-infected population. Coronary artery disease (CAD) results from a combination of increasing age, traditional risk factor such as smoking, toxicity from long-term ART, and potentially related to HIV immune activation.
Most of boosted PIs and the NNRTI [efavirenz] are associated to an increase in triglycerides and total cholesterol plasma levels. In the ANRS CO8 APROCO COPILOTE cohort about 30% of patients developed hypertriglyceridemia. Prevalence of lipodystrophy and metabolic alterations and these alterations appear as early as 12 months after the initiation of PI therapy.
The prevalence of osteopenia and osteoporosis in HIV-infected individuals is higher in HIV-infected compared with HIV-negative individuals ranging, from 23 to 65% for osteopenia and from 3 to 22% for osteoporosis according to the studies [13-16] with, as consequence, a higher prevalence of patients with fracture (p < 0.0001).
Tenofovir is currently the most widely used antiretroviral drug. Globally, clinical trials have suggested that renal toxicity related to tenofovir is low (approximately 1%) in selected populations from clinical studies. However, observational cohort studies have suggested that this risk was higher with rates varying from approximately 2%.
In a systematic review and meta-analysis whereas over time with longer exposure to antiretroviral drugs the overall relative risk of renal disease was 3.87 (95% CI: 2.85-6.85) in HIV-infected patients compared to HIV-uninfected in ART treated patients. 0.54 (95% CI: 0.29-0.99) compared to naïve patients and 1.56 (95% CI: 0.83-2.93) in patients treated with tenofovir compared to patients without tenofovir.
In the DAD study not only tenofovir but also abacavir, lopinavir/ritonavir and atazanavir/ritonavir were associated to high risk.
The use of strategies that could minimize renal toxicity has to be investigated particularly in senior HIV infected population.
Increased risk for drug-drug interactions: a cause of concern in the elderly. Aging increases polypharmacy prescriptions for treatment and prevention of comorbidities such as cardio-vascular disease, hypertension or diabetes. One major issue is the risk for drug-drug interactions in elderly ART treated HIV infected patients due to the common CYP450 cytochrome pathway, shared by ARV drug and drug for comorbidities.
Monitoring concentration of these drugs is not easy in routine practice. Given these drug-drug interactions with potential severe clinical consequences, it is key to investigate alternative ART strategies with different metabolization pathways, such as raltegravir.
Raltegravir and Doravirine: benefits and advantages in terms of toxicity. Overall, literature data showed that raltegravir and doravirine are two drugs with high antiretroviral potency, including in experienced HIV-treated patients, with very good tolerance profile and without expected drug-drug interaction between the two drugs. A new dual therapy strategy combining doravirine + raltegravir given once daily has to be evaluated.
In the setting of dual therapies, and as background the excellent results in terms of efficacy of doravirine plus raltegravir (<2% of virological failure (95% confidence interval 0.3 to 5.0) at week 96 of 165 participants in the ETRAL), we postulate that:
- The association of raltegravir 1200 mg QD and doravirine 100 mg QD (DOR/RAL) will maintain viral suppression in HIV-1-infected patients with suppressed viremia on ART, with a virological failure rate of <12% in a population of 100 patients
- DOR/RAL will be associated to a robust viral suppression with limited amount of blips
- DOR/RAL will be well tolerated over the study period
- Acquired resistance to doravirine or raltegravir will be limited in case of virological failure
- DOR/RAL will present a benefit for patients on metabolic parameters and general symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open label, randomized, switch study, over 96 weeks, in which virally suppressed patients on a stable combined ART regimen will be randomized (2:1) to an immediate switch to doravirine/raltegravir (immediate switch group) or to the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). Patients will be followed during 96 weeks. The randomization will be stratified on gender and antiretroviral regimen at inclusion (Dual therapy or more).
| Arm | Type | Receives |
|---|---|---|
| Delayed switch | Other | Drug: DORAVIRINE 100 MG [Pifeltro]the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). |
| Immediate switch | Experimental | Drug: DORAVIRINE 100 MG [Pifeltro]Immediate switch to doravirine/raltegravir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 copies/mL followed by one HIV-RNA plasma VL ≤ 50 copies/mL)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DORAVIRINE 100 MG [Pifeltro]Also: Raltegravir 600 Mg x 2 [Isentress]Immediate switch | Drug | Delayed switch, Immediate switch |
Primary outcome
Measure the virological efficacy at week 48 of once daily doravirine plus raltegravir dual therapy to assess the effectiveness of the dual therapy DORAL to maintain the virological success to W48
Time frame: 48 weeks
Measure of plasma viral load assessed by RNA quantification using COBA 6800 system (Roche)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Katlama, MD principal investigator
Pitie-Salpetriere Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DORAVIRINE 100 MG [Pifeltro] in people with HIV Infections, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmine Dudoit (33142164181, yasmine.dudoit@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the virological efficacy at week 48 of once daily doravirine plus raltegravir dual therapy to assess the effectiveness of the dual therapy DORAL to maintain the virological success to W48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.