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AzTrials

HIV-1 InfectionPhase 2SWADNCT02067767

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 study testing Abacavir/Lamivudine/Dolutegravir in people with HIV-1 Infection, run by Nantes University Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
Abacavir/Lamivudine/Dolutegravir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesFrance
Study dates
Feb 2014to Dec 2015
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

  • 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
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  • 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

Who cannot join

  • 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),
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  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • La Roche-sur-Yon Hospital

    La Roche-sur-Yon

  • Nantes University Hospital

    Nantes

Other trials in France

About this study

Official title: 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.

Conditions
HIV-1 Infection
Being tested
Abacavir/Lamivudine/Dolutegravir
Keywords
HIV-1 infection, Nevirapine, Dolutegravir, Anti-retroviral agents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abacavir/Lamivudine/DolutegravirDrug

    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.
Study groups in NCT02067767
Study groupRoleWhat they receive
Abacavir/Lamivudine/DolutegravirExperimentalPatients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.
Receives: Drug: Abacavir/Lamivudine/Dolutegravir

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 12

Secondary outcomes (17)

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

    Measured: Week 24

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

    Measured: Week 48

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

    Measured: Week 12

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

    Measured: Week 24

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

    Measured: Week 36

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

    Measured: Week 48

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

    Measured: Week 12

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

    Measured: Week 48

  9. CD4 and CD8 measurement

    Changes in CD4 and CD8 counts over 48 weeks

    Measured: Week 48

  10. Serum creatinine and GFR (MDRD) measurement

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

    Measured: Week 48

  11. Urinary albumine:creatinine ratio measurement

    Change in urinary albumine:creatinine ratio over 48 weeks

    Measured: Week 48

  12. Fasting lipids measurement

    Changes in fasting lipids over 48 weeks

    Measured: 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)

    Measured: 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)

    Measured: Week 12

  15. CD14 and usCRP measurement over 48 weeks

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

    Measured: Week 48

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

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

    Measured: 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)

    Measured: Week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02067767
Sponsor's protocol ID
RC13_0230
Acronym
SWAD
Status last verified
Feb 2015
First submitted
18 Feb 2014
Last updated
22 Feb 2016
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abacavir/Lamivudine/Dolutegravir in people with HIV-1 Infection, run by Nantes University Hospital at 2 sites in France.

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 20 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02067767, which also lists 1 linked publication.

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 22 Feb 2016.

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