Human Immunodeficiency VirusPhase 2MONODONCT02572947
A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients
A Phase 2 study testing Dolutegravir in people with Human Immunodeficiency Virus and Dolutegravir, run by Calmy Alexandra at 1 site in Switzerland.
Trial summary
Current HIV treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (ART). Simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Dolutegravir, Monotherapy
- What is being tested?
- Dolutegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to Sep 2017
- Phase
- Phase 2
- 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 infection;
- Patient included in the Swiss HIV Cohort Study (SHCS);
- ≥ 18 years of age;
- Virologically suppressed for at least 24 months on first line triple ART (changes for toxicity permitted) with at least 4 HIV-1 RNA measurements in plasma <50 copies/ml;
- No history of previous failure on ART;
- No documented antiretroviral drugs resistance;
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- No co-infection with Hepatitis B or C virus;
- Effective contraception in women;
- Willing to provide CSF and semen samples;
- Written informed consent
Who cannot join
- HIV-2 infection;
- Renal dysfunction (creatinine clearance <50ml/min);
- aspartate transaminase or alanine aminotransferase >5x upper limit normal;
- Concomitant use of carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, rifampicin or metformin;
- Previous AIDS defining conditions or active malignancy in the past five years;
- Positive HIV viral load in CSF at baseline;
- Known or suspected non-compliance;
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional, One-arm, Open Label Pilot Study to Assess the Feasibility of Dolutegravir Monotherapy in Virologically Suppressed Patients on Conventional Triple Antiretroviral Therapy of Dolutegravir Plus Two Nucleoside Reverse Transcriptase Inhibitors
Current HIV treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (ART). Simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing virological failure.
- Being tested
- Dolutegravir
- Keywords
- Dolutegravir, HIV infection, Anti-Retroviral Agents, HIV Integrase Inhibitors, Integrase Inhibitors, Pharmacologic Actions, Therapeutic Uses
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir monotherapy | Experimental | 10 patients will be simplified to monotherapy of dolutegravir tablet 50mg once daily for 24 weeks Receives: Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without virological failure defined as plasma HIV-1 RNA ≥ 200 copies/ml on two consecutive measurements or positive HIV-1 RNA level in cerebrospinal fluid (CSF) at week 24 or before
Measured: week 24
Secondary outcomes (8)
Quantification of the HIV-1 DNA reservoir in peripheral blood monocyte cells at baseline and week 24
Measured: week 24
Emergence of genotypic resistance in plasma HIV-1 RNA in case of virological failure
Measured: week 24
Quantification HIV-1 RNA levels in the CSF and semen at baseline and week 24
Lumbar puncture is optional at baseline
Measured: week 24
Change from baseline CD4 cell count from baseline at week 24
Measured: week 24
Adherence to medication at weeks 4, 8, 12, 16, 20, 24
Number of participants with suboptimal adherence defined as more than 3 pills (10%) remaining from previous monthly visit OR missed more than one dose in a row OR missed dose more than once every two weeks
Measured: week 24
Lipidic profile changes from baseline at week 24
Measured: week 24
Body fat composition as measured by dual energy x-ray absorptiometry (DXA) scan at baseline and week 24
Measured: week 24
Change in bone mineral density from baseline to week 24
Number of patients with normal bone density, osteopenia or osteoporosis as defined by DXA scans results
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calmy Alexandra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Calmy Alexandra, University Hospital, Geneva
- Investigators
- Delphine Sculier, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572947
- Sponsor's protocol ID
- PRD-13-2015-I
- Acronym
- MONODO
- Status last verified
- Oct 2017
- First submitted
- 7 Oct 2015
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, One-arm, Open Label Pilot Study to Assess the Feasibility of Dolutegravir Monotherapy in Virologically Suppressed Patients on Conventional Triple Antiretroviral Therapy of Dolutegravir Plus Two Nucleoside Reverse Transcriptase Inhibitors
- ClinicalTrials.gov ID
- NCT02572947
- Acronym / sponsor ID
- MONODO / PRD-13-2015-I
- Keywords
- Dolutegravir, HIV infection, Anti-Retroviral Agents, HIV Integrase Inhibitors, Integrase Inhibitors, Pharmacologic Actions, Therapeutic Uses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Calmy AlexandraUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Oct 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.
Current HIV treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (ART). Simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing virological failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir monotherapy | Experimental | Drug: Dolutegravir10 patients will be simplified to monotherapy of dolutegravir tablet 50mg once daily for 24 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 infection;
- Patient included in the Swiss HIV Cohort Study (SHCS);
- ≥ 18 years of age;
- Virologically suppressed for at least 24 months on first line triple ART (changes for toxicity permitted) with at least 4 HIV-1 RNA measurements in plasma <50 copies/ml;
- No history of previous failure on ART;
Key exclusion criteria (8 listed)
- HIV-2 infection;
- Renal dysfunction (creatinine clearance <50ml/min);
- aspartate transaminase or alanine aminotransferase >5x upper limit normal;
- Concomitant use of carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, rifampicin or metformin;
- Previous AIDS defining conditions or active malignancy in the past five years;
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 | Drug | Dolutegravir monotherapy |
Primary outcome
Number of patients without virological failure defined as plasma HIV-1 RNA ≥ 200 copies/ml on two consecutive measurements or positive HIV-1 RNA level in cerebrospinal fluid (CSF) at week 24 or before
Time frame: week 24
8 secondary outcomes
Quantification of the HIV-1 DNA reservoir in peripheral blood monocyte cells at baseline and week 24
Time frame: week 24
Emergence of genotypic resistance in plasma HIV-1 RNA in case of virological failure
Time frame: week 24
Quantification HIV-1 RNA levels in the CSF and semen at baseline and week 24
Time frame: week 24
Change from baseline CD4 cell count from baseline at week 24
Time frame: week 24
Adherence to medication at weeks 4, 8, 12, 16, 20, 24
Time frame: week 24
Lipidic profile changes from baseline at week 24
Time frame: week 24
Body fat composition as measured by dual energy x-ray absorptiometry (DXA) scan at baseline and week 24
Time frame: week 24
Change in bone mineral density from baseline to week 24
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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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.
Delphine Sculier, MD principal investigator
University Hospital, Geneva
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 Dolutegravir in people with Human Immunodeficiency Virus and Dolutegravir, run by Calmy Alexandra at 1 site in Switzerland.
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 8 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: finished, as of the sponsor's last update on 1 Nov 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients without virological failure defined as plasma HIV-1 RNA ≥ 200 copies/ml on two consecutive measurements or positive HIV-1 RNA level in cerebrospinal fluid (CSF) at week 24 or before (time frame: week 24). 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 1 Nov 2017.