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CompletedNCT02067767SWADUpdated Feb 22, 2016

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)

A Phase 2 interventional study of Abacavir/Lamivudine/Dolutegravir in HIV-1 Infection, sponsored by Nantes University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-22.

Sponsored by Nantes University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • HIV-1 Infection

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Keywords

  • HIV-1 infection
  • Nevirapine
  • Dolutegravir
  • Anti-retroviral agents
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 53 is below the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Abacavir/Lamivudine/Dolutegravir

    Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.

    Drug: Abacavir/Lamivudine/Dolutegravir

Interventions

  • DrugAbacavir/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.

06

What researchers measure

Primary outcomes

  1. Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12

    Time frame: Week 12

Secondary outcomes

  1. Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24

    Time frame: Week 24

  2. Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48

    Time frame: Week 48

  3. Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12

    Time frame: Week 12

  4. Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24

    Time frame: Week 24

  5. Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W36

    Time frame: Week 36

  6. Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48

    Time frame: Week 48

  7. Percentage of patients with adverse event of any Grade over 12 weeks

    Time frame: Week 12

  8. Percentage of patients with adverse event of Grade 3 or 4 over 48 weeks

    Time frame: Week 48

  9. CD4 and CD8 measurement

    Changes in CD4 and CD8 counts over 48 weeks

    Time frame: Week 48

  10. Serum creatinine and GFR (MDRD) measurement

    Changes in serum creatinine, and GFR (MDRD) from W2 to W48

    Time frame: Week 48

  11. Urinary albumine:creatinine ratio measurement

    Change in urinary albumine:creatinine ratio over 48 weeks

    Time frame: Week 48

  12. Fasting lipids measurement

    Changes in fasting lipids over 48 weeks

    Time frame: Week 48

  13. Plasma concentration of NVP between Week 0 (W0) and Week 2 (W2)

    The mean plasma concentration of nevirapine is measured between W0 and W2 (D0, W1, W2)

    Time frame: Week 2

  14. Plasma concentration of dolutegravir between W0 and W12

    The mean plasma concentration of dolutegravir is measured between W0 and W12 (W1, W2, W4, W12)

    Time frame: Week 12

  15. CD14 and usCRP measurement over 48 weeks

    Changes in sCD14 and usCRP over 48 weeks (stored plasma)

    Time frame: Week 48

  16. Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires

    Patient's satisfaction, evaluated with self-administered questionnaires HIVTSQs and HIVTSQc

    Time frame: Week 48

  17. Plasma concentration of DTG on 24h at D0 and Week 2

    24h PK parameters of DTG (D0, after 5 days of combination of ABC/3TC + NVP + DTG) with and without NVP (D14)

    Time frame: Week 2

07

Study locations

2 sites
  • La Roche-sur-Yon Hospital
    La Roche-sur-Yon, France
  • Nantes University Hospital
    Nantes, France
08

References and documents

Publications

  • Dailly E, Allavena C, Gregoire M, Reliquet V, Bouquie R, Billaud E, Hernando H, Bouchez S, Deslandes G, Hall N, Jolliet P, Raffi F. Influence of nevirapine administration on the pharmacokinetics of dolutegravir in patients infected with HIV-1. J Antimicrob Chemother. 2015 Dec;70(12):3307-10. doi: 10.1093/jac/dkv245. Epub 2015 Aug 13. PubMed 26271944 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02067767
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Feb 20, 2014
Start date
Feb 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 22, 2016

Study contacts

François RAFFI, Pr
study chair · Nantes University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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