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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02067767
First received: February 18, 2014
Last updated: September 11, 2014
Last verified: September 2014

February 18, 2014
September 11, 2014
February 2014
December 2015   (final data collection date for primary outcome measure)
Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02067767 on ClinicalTrials.gov Archive Site
  • Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with adverse event of any Grade over 12 weeks [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Percentage of patients with adverse event of Grade 3 or 4 over 48 weeks [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • CD4 and CD8 measurement [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Changes in CD4 and CD8 counts over 48 weeks
  • Serum creatinine and GFR (MDRD) measurement [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Changes in serum creatinine, and GFR (MDRD) from W2 to W48
  • Urinary albumine:creatinine ratio measurement [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Change in urinary albumine:creatinine ratio over 48 weeks
  • Fasting lipids measurement [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Changes in fasting lipids over 48 weeks
  • Plasma concentration of NVP between Week 0 (W0) and Week 2 (W2) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The mean plasma concentration of nevirapine is measured between W0 and W2 (D0, W1, W2)
  • Plasma concentration of dolutegravir between W0 and W12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The mean plasma concentration of dolutegravir is measured between W0 and W12 (W1, W2, W4, W12)
  • CD14 and usCRP measurement over 48 weeks [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Changes in sCD14 and usCRP over 48 weeks (stored plasma)
  • Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Patient's satisfaction, evaluated with self-administered questionnaires HIVTSQs and HIVTSQc
  • Plasma concentration of DTG on 24h at D0 and Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    24h PK parameters of DTG (D0, after 5 days of combination of ABC/3TC + NVP + DTG) with and without NVP (D14)
Same as current
Not Provided
Not Provided
 
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)
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
Drug: Abacavir/Lamivudine/Dolutegravir

At Day 1 (D1):

  • group 1 will switch their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG ;
  • group 2 will continue NVP and switch ABC/3TC to ABC/3TC/DTG for 6 days (D-5 to D0), then stop NVP from D1.
Experimental: Abacavir/Lamivudine/Dolutegravir
Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.
Intervention: Drug: Abacavir/Lamivudine/Dolutegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
53
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: François RAFFI, Pr 02 40 08 31 10 francois.raffi@chu-nantes.fr
Contact: Clotilde ALLAVENA, Dr 02 40 08 31 10 clotilde.allavena@chu-nantes.fr
France
 
NCT02067767
RC13_0230
Yes
Nantes University Hospital
Nantes University Hospital
Not Provided
Study Chair: François RAFFI, Pr Nantes University Hospital
Nantes University Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP