HIVPhase 3MONCAYNCT02596334
Study to Evaluate the Efficacy of MONotherapy of TiviCAY® Versus a Triple Therapy in HIV-1-infected Patients
A Phase 3 study testing dolutegravir 50mg +abacavir 600mg +lamivudine 300mg and dolutegravir in people with HIV, run by Centre Hospitalier Régional d'Orléans at 9 sites in France.
Trial summary
Triple antiretroviral regimens have greatly improved the prognosis of patients living with HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have a life expectancy close or equal to that of people not infected with HIV.[1] However, this is under the condition of a "lifetime"… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- dolutegravir 50mg +abacavir 600mg +lamivudine 300mg and dolutegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 9 sitesFrance
- Study dates
- 23 Dec 2015to 23 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- HIV-1-infected patients with no previous AIDS event (excluding a healed tuberculosis);
- Current antiretroviral treatment associating dolutegravir + abacavir + lamivudine for at least 1 month;
- Nadir CD4 ≥ 100/mm3;
- Plasma RNA viral load < 50 copies/ml for at least 12 months;
- Plasma RNA viral load <20 or 40 copies/ml (according to the threshold of the method used by local laboratory) at the screening visit;
- No documented virologic failure or known resistance to any integrase inhibitor,
Show all 10Show fewer
- Patient having provided a written consent;
- Patients follow-up possible in ambulatory;
- Patient age > 18 years;
- Covered by health insurance
Who cannot join
- Non-compliant patient
- Subject is pregnant, or lactating, or of childbearing potential and without contraception;
- Active opportunistic infections (defining AIDS);
- Known hypersensibility to abacavir or lamivudine or dolutegravir;
- Patients harboring HLA B*5701;
- Major overweight (BMI ≥ 40);
Show all 18Show fewer
- Weight <40 kg;
- Creatinine clearance < 50ml/min;
- Cirrhosis or severe liver failure (factor V < 50%);
- Life Prognosis threatened within 6 months;
- Circumstances that may impair judgment or understanding of the information given to the patient;
- Co-medication with carbamazepin, oxcarbamazepin, fosphenytoïn, phenobarbital, phenytoïn, primidon, St John's wort or dofetilid;
- Malabsorption syndromes;
- The following laboratory criteria:
- Serum AST,ALT > 5 x upper limit of normal (ULN)
- Thrombocytopenia with platelet count < 50.000/ml
- Anemia with hemoglobin < 8g/dl
- Polynuclear neutrophil count < 500/mm3
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHD de VENDEE
La Roche-sur-Yon, 85925
CH de LA ROCHELLE
La Rochelle, 17019
CHRU de NANTES
Nantes, 44093
CH de NIORT
Niort, 79021
CHR d'ORLEANS
Orléans, 45032
CHRU de POITIERS
Poitiers, 86021
CHU de STRASBOURG
Strasbourg, 67000
CHRU de TOURS
Tours, 37044
CHU de NANCY
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy of a Dolutegravir Monotherapy (Tivicay®) Versus the Maintenance of a Successful Triple Therapy Using Abacavir + Lamivudine + Dolutegravir (Triumeq®) in HIV-1- Infected Patients
Triple antiretroviral regimens have greatly improved the prognosis of patients living with HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have a life expectancy close or equal to that of people not infected with HIV.[1] However, this is under the condition of a "lifetime" maintenance of an undetectable plasma viral load (pVL) (<50 cp/ml). On the other hand it is well established that aging increases comorbidities among PLHIV and the burden of co-medications.[2] This also has the consequence of frequent drug-drug interactions. In this context it is important to decrease pills burden, side-effects and drug-drug interactions, while maintaining undetectability.
Currently, there is a strong interest for medical research to validate lightened regimens (i.e. bithérapies [3-7] and monothérapies [8,9], particularly in a maintenance strategy, with the primary objective of reducing burden of pills and side effects. Several monotherapy trials using a boosted protease inhibitor (PI/r) showed high level of viral suppression, even if this proportion was not always non-inferior to maintaining a triple therapy. [8,9] Fortunately, when virological failure occurred under monotherapy virologic suppression was easily restored by the addition of two NRTI. Patients who are most likely to maintain viral suppression under a reduced scheme are those that have a high nadir (> 100 CD4 / mm3), no previous AIDS event and a sustained virologic suppression (>12 months).
Monotherapy is the option that best reduces the burden of pills and the risk of side effects or drug-drug interactions. It must be considered using very powerful molecule that harbor a strong binding to its ligand in order to minimize the risk of selecting resistant mutants in the case of virologic failure. To be as simple as possible in its use, it must be a single agent administered as a single dose once a day and not boosted if possible. The molecule must have very good tolerance. Finally, to be effective in viral sanctuaries this molecule should have a good (or sufficient) diffusion to ensure effective Cmin on wild viral strains. Dolutegravir meets all these exigences.[10] In addition, our team recently presented results of a pilot study showing that the switch of a successful combined antiretroviral regimen to dolutegravir monotherapy maintained undetectable viral load (<20 cp/ml) after a median of 7 months (range 6.5-10 months).
- Conditions
- HIV
- Being tested
- dolutegravir 50mg +abacavir 600mg +lamivudine 300mg, dolutegravir
- Keywords
- HIV-1 infected patient, monotherapy, dolutegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dolutegravir 50mg +abacavir 600mg +lamivudine 300mgDrug
Also called Triumeq, EU/1/14/940/001
dolutegravirDrug
Also called Tivicay , EU/1/13/892/001
| Study group | Role | What they receive |
|---|---|---|
| triple therapy | Active comparator | dolutegravir + abacavir + lamivudine (TRIUMEQ) : oral administration, one tablet daily during 48 weeks. Receives: Drug: dolutegravir 50mg +abacavir 600mg +lamivudine 300mg |
| monotherapy | Experimental | dolutegravir (TIVICAY) : 50 mg, oral administration, one tablet daily during 48 weeks. Receives: Drug: dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load
Percentage of patients having a viral load <50 copies/ml in each arm at week 24
Measured: Week 24
Secondary outcomes (16)
Viral load
Percentage of patients having a confirmed viral load > 50 copies/ml between week 4 and week 48
Measured: between Week 4 and Week 48
Delta CD 4
delta CD4 in each arms from Baseline to W48, comparison between arms
Measured: until Week 48
Residual activation measures (sub study)
CD4+CD38+DR+, CD8+CD38+DR+
Measured: Week 24
Residual activation marker measures (sub study)
sCD14, sCD163,
Measured: Week 24
Pro-inflammatory cytokins measures (sub study)
TNFα, IFNγ, IL6, IP-10
Measured: Week 24
Inflammatory marker measures (sub study)
CRPus
Measured: Week 24
virus genotype
Evolution of viruses genotype profiles of patients who present a virologic failure
Measured: Until Week 48
RNA and DNA viral load (sub study)
RNA and DNA viral load in the genital tract (cervico-vaginal secretions or sperm): comparison between arms
Measured: Week 24 to week 48
HIV DNA evolution
HIV DNA evolution in each arm from baseline to W48; comparison between arms
Measured: between day 0 and week 48
Virological failure predictive factors
Determination of virological failure predictive factors
Measured: 48 weeks
Impact of the strategy on the acceptability and quality of life
determination of quality of life with questionnary, comparison between arms
Measured: 48 weeks
Proportion of patients with an adverse event
Measured: 48 weeks
Proportion of patients with a severe adverse event
Measured: 48 weeks
Creatinine clearance change
Biological parameters evolution in each arm
Measured: 48 weeks
Lipidic profiles
Biological parameters evolution in each arm
Measured: 48 weeks
Clinical events
Clinical events with progression to AIDS or death. Proportion of individuals developing a new CDC-event (as defined by cdc 1993 classification) from baseline to week 48.
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 posted4 Nov 2015 (estimated)
- Study start23 Dec 2015
- Primary completion23 Jun 2017
- Study completion23 Jun 2018
Why it stopped: 5 patients on tivicay had virological failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HOCQUELOUX Laurent, Study director, CHR d'ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596334
- Sponsor's protocol ID
- CHRO 2015-03
- Acronym
- MONCAY
- Status last verified
- Nov 2018
- First submitted
- 16 Oct 2015
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
May MT, Gompels M, Delpech V, Porter K, Orkin C, Kegg S, Hay P, Johnson M, Palfreeman A, Gilson R, Chadwick D, Martin F, Hill T, Walsh J, Post F, Fisher M, Ainsworth J, Jose S, Leen C, Nelson M, Anderson J, Sabin C; UK Collaborative HIV Cohort (UK CHIC) Study. Impact on life expectancy of HIV-1 positive individuals of CD4+ cell count and viral load response to antiretroviral therapy. AIDS. 2014 May 15;28(8):1193-202. doi: 10.1097/QAD.0000000000000243.
PubMed 24556869Nachega JB, Parienti JJ, Uthman OA, Gross R, Dowdy DW, Sax PE, Gallant JE, Mugavero MJ, Mills EJ, Giordano TP. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials. Clin Infect Dis. 2014 May;58(9):1297-307. doi: 10.1093/cid/ciu046. Epub 2014 Jan 22.
PubMed 24457345Cahn P, Andrade-Villanueva J, Arribas JR, Gatell JM, Lama JR, Norton M, Patterson P, Sierra Madero J, Sued O, Figueroa MI, Rolon MJ; GARDEL Study Group. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014 Jul;14(7):572-80. doi: 10.1016/S1473-3099(14)70736-4. Epub 2014 Apr 27.
PubMed 24783988Prazuck T, Zucman D, Avettand-Fenoel V, Ducasse E, Bornarel D, Mille C, Rouzioux C, Hocqueloux L. Long-term HIV-1 virologic control in patients on a dual NRTI regimen. HIV Clin Trials. 2013 May-Jun;14(3):120-6. doi: 10.1310/hct1403-120.
PubMed 23835514Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.
PubMed 22180523Calin R, Paris L, Simon A, Peytavin G, Wirden M, Schneider L, Valantin MA, Tubiana R, Agher R, Katlama C. Dual raltegravir/etravirine combination in virologically suppressed HIV-1-infected patients on antiretroviral therapy. Antivir Ther. 2012;17(8):1601-4. doi: 10.3851/IMP2344. Epub 2012 Sep 3.
PubMed 22941896Monteiro P, Perez I, Laguno M, Martinez-Rebollar M, Gonzalez-Cordon A, Lonca M, Mallolas J, Blanco JL, Gatell JM, Martinez E. Dual therapy with etravirine plus raltegravir for virologically suppressed HIV-infected patients: a pilot study. J Antimicrob Chemother. 2014 Mar;69(3):742-8. doi: 10.1093/jac/dkt406. Epub 2013 Oct 14.
PubMed 24128667Katlama C, Valantin MA, Algarte-Genin M, Duvivier C, Lambert-Niclot S, Girard PM, Molina JM, Hoen B, Pakianather S, Peytavin G, Marcelin AG, Flandre P. Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS. 2010 Sep 24;24(15):2365-74. doi: 10.1097/QAD.0b013e32833dec20.
PubMed 20802297Arribas JR, Horban A, Gerstoft J, Fatkenheuer G, Nelson M, Clumeck N, Pulido F, Hill A, van Delft Y, Stark T, Moecklinghoff C. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS. 2010 Jan 16;24(2):223-30. doi: 10.1097/QAD.0b013e3283348944.
PubMed 20010070Greig SL, Deeks ED. Abacavir/dolutegravir/lamivudine single-tablet regimen: a review of its use in HIV-1 infection. Drugs. 2015 Apr;75(5):503-14. doi: 10.1007/s40265-015-0361-6.
PubMed 25698454Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Seve A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fenoel V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.
PubMed 31350995Hocqueloux L, Raffi F, Prazuck T, Bernard L, Sunder S, Esnault JL, Rey D, Le Moal G, Roncato-Saberan M, Andre M, Billaud E, Valery A, Avettand-Fenoel V, Parienti JJ, Allavena C; MONCAY study group. Dolutegravir Monotherapy Versus Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial. Clin Infect Dis. 2019 Oct 15;69(9):1498-1505. doi: 10.1093/cid/ciy1132.
PubMed 30601976
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of a Dolutegravir Monotherapy (Tivicay®) Versus the Maintenance of a Successful Triple Therapy Using Abacavir + Lamivudine + Dolutegravir (Triumeq®) in HIV-1- Infected Patients
- ClinicalTrials.gov ID
- NCT02596334
- Acronym / sponsor ID
- MONCAY / CHRO 2015-03
- Conditions
- HIV
- Keywords
- HIV-1 infected patient, monotherapy, dolutegravir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 5 patients on tivicay had virological failure
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 23 Jun 2018 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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.
Triple antiretroviral regimens have greatly improved the prognosis of patients living with HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have a life expectancy close or equal to that of people not infected with HIV.[1] However, this is under the condition of a "lifetime" maintenance of an undetectable plasma viral load (pVL) (<50 cp/ml). On the other hand it is well established that aging increases comorbidities among PLHIV and the burden of co-medications.[2] This also has the consequence of frequent drug-drug interactions. In this context it is important to decrease pills burden, side-effects and drug-drug interactions, while maintaining undetectability.
Currently, there is a strong interest for medical research to validate lightened regimens (i.e. bithérapies [3-7] and monothérapies [8,9], particularly in a maintenance strategy, with the primary objective of reducing burden of pills and side effects. Several monotherapy trials using a boosted protease inhibitor (PI/r) showed high level of viral suppression, even if this proportion was not always non-inferior to maintaining a triple therapy. [8,9] Fortunately, when virological failure occurred under monotherapy virologic suppression was easily restored by the addition of two NRTI. Patients who are most likely to maintain viral suppression under a reduced scheme are those that have a high nadir (> 100 CD4 / mm3), no previous AIDS event and a sustained virologic suppression (>12 months).
Monotherapy is the option that best reduces the burden of pills and the risk of side effects or drug-drug interactions. It must be considered using very powerful molecule that harbor a strong binding to its ligand in order to minimize the risk of selecting resistant mutants in the case of virologic failure. To be as simple as possible in its use, it must be a single agent administered as a single dose once a day and not boosted if possible. The molecule must have very good tolerance. Finally, to be effective in viral sanctuaries this molecule should have a good (or sufficient) diffusion to ensure effective Cmin on wild viral strains. Dolutegravir meets all these exigences.[10] In addition, our team recently presented results of a pilot study showing that the switch of a successful combined antiretroviral regimen to dolutegravir monotherapy maintained undetectable viral load (<20 cp/ml) after a median of 7 months (range 6.5-10 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple therapy | Active comparator | Drug: dolutegravir 50mg +abacavir 600mg +lamivudine 300mgdolutegravir + abacavir + lamivudine (TRIUMEQ) : oral administration, one tablet daily during 48 weeks. |
| monotherapy | Experimental | Drug: dolutegravirdolutegravir (TIVICAY) : 50 mg, oral administration, one tablet daily during 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HIV-1-infected patients with no previous AIDS event (excluding a healed tuberculosis);
- Current antiretroviral treatment associating dolutegravir + abacavir + lamivudine for at least 1 month;
- Nadir CD4 ≥ 100/mm3;
- Plasma RNA viral load < 50 copies/ml for at least 12 months;
- Plasma RNA viral load <20 or 40 copies/ml (according to the threshold of the method used by local laboratory) at the screening visit;
Key exclusion criteria (18 listed)
- Non-compliant patient
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 |
|---|---|---|
| dolutegravir 50mg +abacavir 600mg +lamivudine 300mgAlso: Triumeq, EU/1/14/940/001 | Drug | triple therapy |
| dolutegravirAlso: Tivicay , EU/1/13/892/001 | Drug | monotherapy |
Primary outcome
Viral Load
Time frame: Week 24
Percentage of patients having a viral load <50 copies/ml in each arm at week 24
16 secondary outcomes
Viral load
Time frame: between Week 4 and Week 48
Delta CD 4
Time frame: until Week 48
Residual activation measures (sub study)
Time frame: Week 24
Residual activation marker measures (sub study)
Time frame: Week 24
Pro-inflammatory cytokins measures (sub study)
Time frame: Week 24
Inflammatory marker measures (sub study)
Time frame: Week 24
virus genotype
Time frame: Until Week 48
RNA and DNA viral load (sub study)
Time frame: Week 24 to week 48
HIV DNA evolution
Time frame: between day 0 and week 48
Virological failure predictive factors
Time frame: 48 weeks
Impact of the strategy on the acceptability and quality of life
Time frame: 48 weeks
Proportion of patients with an adverse event
Time frame: 48 weeks
Proportion of patients with a severe adverse event
Time frame: 48 weeks
Creatinine clearance change
Time frame: 48 weeks
Lipidic profiles
Time frame: 48 weeks
Clinical events
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: 5 patients on tivicay had virological failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Background: PubMed 24556869May MT, Gompels M, Delpech V, Porter K, Orkin C, Kegg S, Hay P, Johnson M, Palfreeman A, Gilson R, Chadwick D, Martin F, Hill T, Walsh J, Post F, Fisher M, Ainsworth J, Jose S, Leen C, Nelson M, Anderson J, Sabin C; UK Collaborative HIV Cohort (UK CHIC) Study. Impact on life expectancy of HIV-1 positive individuals of CD4+ cell count and viral load response to antiretroviral therapy. AIDS. 2014 May 15;28(8):1193-202. doi: 10.1097/QAD.0000000000000243.
- Background: PubMed 24457345Nachega JB, Parienti JJ, Uthman OA, Gross R, Dowdy DW, Sax PE, Gallant JE, Mugavero MJ, Mills EJ, Giordano TP. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials. Clin Infect Dis. 2014 May;58(9):1297-307. doi: 10.1093/cid/ciu046. Epub 2014 Jan 22.
- Background: PubMed 24783988Cahn P, Andrade-Villanueva J, Arribas JR, Gatell JM, Lama JR, Norton M, Patterson P, Sierra Madero J, Sued O, Figueroa MI, Rolon MJ; GARDEL Study Group. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014 Jul;14(7):572-80. doi: 10.1016/S1473-3099(14)70736-4. Epub 2014 Apr 27.
- Background: PubMed 23835514Prazuck T, Zucman D, Avettand-Fenoel V, Ducasse E, Bornarel D, Mille C, Rouzioux C, Hocqueloux L. Long-term HIV-1 virologic control in patients on a dual NRTI regimen. HIV Clin Trials. 2013 May-Jun;14(3):120-6. doi: 10.1310/hct1403-120.
- Background: PubMed 22180523Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.
- Background: PubMed 22941896Calin R, Paris L, Simon A, Peytavin G, Wirden M, Schneider L, Valantin MA, Tubiana R, Agher R, Katlama C. Dual raltegravir/etravirine combination in virologically suppressed HIV-1-infected patients on antiretroviral therapy. Antivir Ther. 2012;17(8):1601-4. doi: 10.3851/IMP2344. Epub 2012 Sep 3.
- Background: PubMed 24128667Monteiro P, Perez I, Laguno M, Martinez-Rebollar M, Gonzalez-Cordon A, Lonca M, Mallolas J, Blanco JL, Gatell JM, Martinez E. Dual therapy with etravirine plus raltegravir for virologically suppressed HIV-infected patients: a pilot study. J Antimicrob Chemother. 2014 Mar;69(3):742-8. doi: 10.1093/jac/dkt406. Epub 2013 Oct 14.
- Background: PubMed 20802297Katlama C, Valantin MA, Algarte-Genin M, Duvivier C, Lambert-Niclot S, Girard PM, Molina JM, Hoen B, Pakianather S, Peytavin G, Marcelin AG, Flandre P. Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS. 2010 Sep 24;24(15):2365-74. doi: 10.1097/QAD.0b013e32833dec20.
- Background: PubMed 20010070Arribas JR, Horban A, Gerstoft J, Fatkenheuer G, Nelson M, Clumeck N, Pulido F, Hill A, van Delft Y, Stark T, Moecklinghoff C. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS. 2010 Jan 16;24(2):223-30. doi: 10.1097/QAD.0b013e3283348944.
- Background: PubMed 25698454Greig SL, Deeks ED. Abacavir/dolutegravir/lamivudine single-tablet regimen: a review of its use in HIV-1 infection. Drugs. 2015 Apr;75(5):503-14. doi: 10.1007/s40265-015-0361-6.
- Derived from this study: PubMed 31350995Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Seve A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fenoel V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.
- Derived from this study: PubMed 30601976Hocqueloux L, Raffi F, Prazuck T, Bernard L, Sunder S, Esnault JL, Rey D, Le Moal G, Roncato-Saberan M, Andre M, Billaud E, Valery A, Avettand-Fenoel V, Parienti JJ, Allavena C; MONCAY study group. Dolutegravir Monotherapy Versus Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial. Clin Infect Dis. 2019 Oct 15;69(9):1498-1505. doi: 10.1093/cid/ciy1132.
Related trials for HIV
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. This study is not recruiting at the moment.
HOCQUELOUX Laurent study director
CHR d'ORLEANS
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dolutegravir 50mg +abacavir 600mg +lamivudine 300mg and dolutegravir in people with HIV, run by Centre Hospitalier Régional d'Orléans at 9 sites 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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 5 patients on tivicay had virological failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Load (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596334, which also lists 12 linked publications.
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 13 Nov 2018.