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NCT05030025
Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)
EARLY_PHASE1 trial testing abacavir, dolutegravir and lamivudine dispersible tablets in HIV-1-infection in 43 participants. Completed in 29 August 2021.
29 August 2021
Quick facts
| Lead sponsor | Mylan Inc. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 1 August 2021 |
| Primary completion | 29 August 2021 |
| Estimated completion | 29 August 2021 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- abacavir, dolutegravir and lamivudine dispersible tablets
- Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine
Conditions studied
- HIV-1-infection — all drugs for HIV-1-infection →
Sponsor
Mylan Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The rationale for this study is to evaluate and understand the variability of a generic alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR submission to aide in the development of pivotal studies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05030025
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Mylan Inc. trials
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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 NCT05030025 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mylan Inc.
- Last refreshed: 25 March 2022
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/NCT05030025.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing