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NCT02067767: 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

Completed Phase 2 Last updated 19 February 2016
What this trial tests

Phase 2 trial testing Abacavir/Lamivudine/Dolutegravir in HIV-1 Infection in 53 participants. Completed in 1 December 2015.

Timeline
1 February 2014
Primary endpoint
1 December 2015
1 December 2015

Quick facts

Lead sponsorNantes University Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment53
Start date1 February 2014
Primary completion1 December 2015
Estimated completion1 December 2015
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Influence of nevirapine administration on the pharmacokinetics of dolutegravir in patients infected with HIV-1.
    Dailly E, Allavena C, Grégoire M, Reliquet V, et al · · 2015 · cited 7× · PMID 26271944 · DOI 10.1093/jac/dkv245

Verify or expand the search:

Other recruiting trials for HIV-1 Infection

Currently open trials in the same condition.

Other Nantes University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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