- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02067767
Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults (SWAD) (SWAD)
February 19, 2016 updated by: Nantes University Hospital
Phase 2 Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults
Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable regimen on the long-term.
However this regimen comprises 2 pills per day.
Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP) of high potency, higher genetic barrier to resistance, with a very good safety profile.
The objective of this study is to evaluate the virologic safety (maintenance of virologic suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory safety.
Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK) assessment will be performed in all patients in the first weeks after switch and 24-hours PK in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching to ABC/3TC/DTG.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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La Roche-sur-Yon, France
- La Roche-sur-Yon Hospital
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Nantes, France
- Nantes University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient with confirmed HIV-1 infection (HIV antibody positive confirmation prior to screening)
- Age ≥ 18 years
- Written informed consent
- Male patient or non-pregnant, non-lactating female patient
- On antiretroviral treatment with nevirapine (400 mg per day) plus abacavir/lamivudine for more than 6 months; Nevirapine 400 mg/day being administered as either 1 x 200 mg IR x 2/day or 2 x 200 mg IR qd or 1 x 400 mg XR qd
- No history of prior virologic failure on antiretroviral therapy
- HIV-1 RNA < 50 copies/ml for more than 1 year,
- No major IAS-USA nucleoside reverse transcriptase inhibitors or integrase inhibitors resistance mutations on genotypic testing on last plasma sample with HIV-1 RNA > 500 c/mL (if available)
- HLA-B*5701 negative test
- Subjects covered by Health Insurance
Exclusion Criteria:
- Woman of child-bearing potential without effective contraception method. Pregnant or breastfeeding woman.
- Woman expecting to conceive during the study period
- HIV-2 co-infection
- Any prior exposure to integrase inhibitor(s)
- Plasma HIV-1 RNA > 50 c/mL in the past year
- Creatinine clearance < 60 ml/mn (estimated glomerular filtration rate according to the MDRD equation),
- Alkaline phosphatase, ASAT or ALAT ≥ 5 times the upper limit of the norm (ULN)
- Patient with history of decompensated liver disease
- Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or integrase inhibitors on any historical plasma genotype if available. Any previous genotype result is valid, with no time limit, as long as the original test result is documented.
- Mycobacteriosis under treatment
- Malignancy requiring chemotherapy or radiotherapy
- Positive HBs Ag
- HCV infection for which specific treatment is ongoing or planned during the study
- Known hypersensitivity to one of the trial drugs, the metabolites or formulation excipients
- Concomitant therapy with antacids or H2 antagonists
- Contraindicated concomitant treatment
- Anticipated non-compliance with the protocol
- Participation in another clinical trial with an on-going exclusion period at screening
- Subject under legal guardianship or incapacitation
- Subject, who in the opinion of the investigator, is unable to complete the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abacavir/Lamivudine/Dolutegravir
Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.
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At Day 1 (D1):
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12
Time Frame: Week 12
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Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24
Time Frame: Week 24
|
Week 24
|
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Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48
Time Frame: Week 48
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Week 48
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Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12
Time Frame: Week 12
|
Week 12
|
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Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24
Time Frame: Week 24
|
Week 24
|
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Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W36
Time Frame: Week 36
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Week 36
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Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48
Time Frame: Week 48
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Week 48
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Percentage of patients with adverse event of any Grade over 12 weeks
Time Frame: Week 12
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Week 12
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Percentage of patients with adverse event of Grade 3 or 4 over 48 weeks
Time Frame: Week 48
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Week 48
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CD4 and CD8 measurement
Time Frame: Week 48
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Changes in CD4 and CD8 counts over 48 weeks
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Week 48
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Serum creatinine and GFR (MDRD) measurement
Time Frame: Week 48
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Changes in serum creatinine, and GFR (MDRD) from W2 to W48
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Week 48
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Urinary albumine:creatinine ratio measurement
Time Frame: Week 48
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Change in urinary albumine:creatinine ratio over 48 weeks
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Week 48
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Fasting lipids measurement
Time Frame: Week 48
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Changes in fasting lipids over 48 weeks
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Week 48
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Plasma concentration of NVP between Week 0 (W0) and Week 2 (W2)
Time Frame: Week 2
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The mean plasma concentration of nevirapine is measured between W0 and W2 (D0, W1, W2)
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Week 2
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Plasma concentration of dolutegravir between W0 and W12
Time Frame: Week 12
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The mean plasma concentration of dolutegravir is measured between W0 and W12 (W1, W2, W4, W12)
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Week 12
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CD14 and usCRP measurement over 48 weeks
Time Frame: Week 48
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Changes in sCD14 and usCRP over 48 weeks (stored plasma)
|
Week 48
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Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires
Time Frame: Week 48
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Patient's satisfaction, evaluated with self-administered questionnaires HIVTSQs and HIVTSQc
|
Week 48
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Plasma concentration of DTG on 24h at D0 and Week 2
Time Frame: Week 2
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24h PK parameters of DTG (D0, after 5 days of combination of ABC/3TC + NVP + DTG) with and without NVP (D14)
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Week 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: François RAFFI, Pr, Nantes University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 18, 2014
First Submitted That Met QC Criteria
February 19, 2014
First Posted (Estimate)
February 20, 2014
Study Record Updates
Last Update Posted (Estimate)
February 22, 2016
Last Update Submitted That Met QC Criteria
February 19, 2016
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC13_0230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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