Early Simplified: A Trial to Compare the Efficacy of Standard of Care Combination Antiretroviral Therapy With a Simplified Dolutegravir Monotherapy in Patients With a Primary HIV-1 Infection
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ClinicalTrials.gov Identifier: NCT02551523 |
Recruitment Status : Unknown
Verified October 2018 by University of Zurich.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : October 12, 2018
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Condition or disease | Intervention/treatment | Phase |
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Monotherapy Dolutegravir Primary HIV Infection Treatment Efficacy | Drug: Dolutegravir Drug: Standard of care combinational antiretroviral therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomised, Controlled, Open-label, Non-inferiority Trial to Compare the Efficacy of Standard of Care Combination Antiretroviral Therapy With a Simplified Dolutegravir Monotherapy in Patients With a Primary HIV-1 Infection Under Suppressive Early Standard of Care Antiretroviral Therapy |
Study Start Date : | November 2016 |
Estimated Primary Completion Date : | October 2018 |
Estimated Study Completion Date : | February 2021 |
Arm | Intervention/treatment |
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Experimental: Dolutegravir monotherapy
92 patients will be simplified to once daily dolutegravir monotherapy.
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Drug: Dolutegravir
92 patients will be simplified to once daily dolutegravir monotherapy |
Active Comparator: Standard of care combination antiretroviral therapy
46 patients will go on with standard of care combination antiretroviral therapy consisting of either a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor or a integrase inhibitor in combination with two nucleoside reverse transcriptase inhibitors.
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Drug: Standard of care combinational antiretroviral therapy |
- Proportion of individuals with a viral failure [defined as ≥2 plasma viremia levels >50copies/ml at least two weeks apart] at week 48 or before. [ Time Frame: 48 weeks ]The study seeks primarily to determine the efficacy (i.e., proportion of patients with a viral failure [defined as ≥2 plasma viremia levels >50copies/ml at least two weeks apart] at week 48 or before) of a simplified monotherapy (i.e., DTG) compared to a standard of care HIV triple-therapy in patients with a PHI treated with early ART under long term suppressive ART for at least 48 weeks.
- Quantification of latent HIV-1 reservoir by measurement of proviral DNA and cell-associated RNA at baseline (time point of randomization), and at week 48 [ Time Frame: Week48 ]
- Proportion of individuals with a CSF HIV-1 RNA <50copies/ml in the CSF at week 48 after treatment simplification. [ Time Frame: Week 48 ]
- Proportion of patients with an adverse event at week 48. [ Time Frame: Week 48 ]
- Proportion of patients with a severe adverse event at week 48. [ Time Frame: Week 48 ]
- Time to viral failure (defined as ≥2 plasma viremia levels >50copies/ml at least two weeks apart) at week 48. [ Time Frame: Week 48 ]
- Proportion of individuals with blips (defined as one viral load >50 and <400 copies/ml with a next viral load <50 copies/ml) at week 48. [ Time Frame: Week 48 ]
- Change from baseline CD4+ cell count from baseline at week 48. [ Time Frame: Week 48 ]
- Proportion of individuals with new onset of proximal tubular renal dysfunction at week 48. [ Time Frame: Week 48 ]
- Creatinine clearance change from baseline at week 48. [ Time Frame: Week 48 ]
- Lipidic profile changes from baseline at week 48. [ Time Frame: Week 48 ]
- Proportion of individuals developing a new CDC-event at week 48. [ Time Frame: Week 48 ]
- Proportion of individuals withdrawing consent at week 48. [ Time Frame: Week 48 ]
- Proportion of individuals being lost to follow-up at week 48. [ Time Frame: Week 48 ]
- Proportion of individuals switching assigned treatment for any cause at week 48. [ Time Frame: Week 48 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Informed Consent as documented by signature,
- All patients ≥18 years with a documented primary HIV-infection undergoing standard of care cART (i.e., one active drug from the class of either the PIs, or the NNRTIs, or the INSTIs, in combination with two active drugs from the class of NRTIs) with no previous structured treatment interruption and with a suppressed viral load (defined as 50 copies/ml) during the previous 48 weeks,
- Participant of the Swiss HIV Cohort Study
Exclusion Criteria:
- Patients not willing to sign the informed consent form,
- Presence of ≥1 major integrase inhibitor resistance associated mutation according to the Sanford algorithm1,
- History of ≥2 consecutive plasma viremia levels >400 copies/ml at least two weeks apart,
- Ongoing (i.e., replicating) hepatitis B virus infection,
- Hemoglobin < 10 g/dl (men) and < 9 g/dl (women) at the time of enrolment,
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Lack of safe contraception,
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551523
Switzerland | |
University Hospital Zurich, University of Zurich | |
Zurich, Switzerland, 8091 |
Principal Investigator: | Dominique L Braun, MD | Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich |
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT02551523 |
Other Study ID Numbers: |
KEK-ZH-Nr. 2015-0288 |
First Posted: | September 16, 2015 Key Record Dates |
Last Update Posted: | October 12, 2018 |
Last Verified: | October 2018 |
Infections Communicable Diseases Disease Attributes Pathologic Processes Dolutegravir Anti-Retroviral Agents HIV Integrase Inhibitors |
Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Antiviral Agents Anti-Infective Agents |