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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
Phase 2 trial testing Abacavir/Lamivudine/Dolutegravir in HIV-1 Infection in 53 participants. Completed in 1 December 2015.
1 December 2015
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 1 February 2014 |
| Primary completion | 1 December 2015 |
| Estimated completion | 1 December 2015 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Abacavir/Lamivudine/Dolutegravir — full drug profile →
Conditions studied
- HIV-1 Infection — all drugs for HIV-1 Infection →
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.
-
Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12
Time frame: Week 12
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):
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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:
- PubMed search for NCT02067767
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT05631093 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting
- NCT05630755 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting
Other Nantes University Hospital trials
Trials by the same sponsor.
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- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02067767 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 19 February 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02067767.
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