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NCT03515772
Drug-drug Interactions Between Antiretroviral Drugs and Cardiovascular Drugs in Elderly Patients
trial testing Co-administration of darunavir with a cardiovascular drug in HIV Infections in 21 participants. Completed in 29 August 2019.
29 August 2019
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire Vaudois |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 21 |
| Start date | 23 April 2018 |
| Primary completion | 29 August 2019 |
| Estimated completion | 29 August 2019 |
| Sites | 2 locations across Switzerland |
Drugs / interventions tested
- Co-administration of darunavir with a cardiovascular drug — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
- Drug Interactions — all drugs for Drug Interactions →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
Sponsor
Centre Hospitalier Universitaire Vaudois
Who can join
Eligibility, any sex, with HIV Infections or Drug Interactions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Ageing is characterized by physiological changes, which can impact drug pharmacokinetics and thereby cause drug-drug interactions. This study aims to assess the pharmacokinetics of amlodipine, atorvastatin and rosuvastatin in the presence of darunavir/ritonavir (inhibitor of drug metabolizing enzymes and drug transporters), by comparison with dolutegravir (no inhibitory effects on cytochromes or transporters involved in the disposition of the evaluated co-medications), in order to characterize the importance of drug-drug interactions in elderly individuals.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Population pharmacokinetic modelling to quantify the magnitude of drug-drug interactions between amlodipine and antiretroviral drugs.
Courlet P, Guidi M, Alves Saldanha S, Cavassini M, et al · · 2021 · cited 10× · PMID 33452585 · DOI 10.1007/s00228-020-03060-2 -
Pharmacokinetic/Pharmacodynamic Modelling to Describe the Cholesterol Lowering Effect of Rosuvastatin in People Living with HIV.
Courlet P, Guidi M, Alves Saldanha S, Stader F, et al · · 2021 · cited 5× · PMID 33124006 · DOI 10.1007/s40262-020-00946-3 -
Influence of Drug-Drug Interactions on the Pharmacokinetics of Atorvastatin and Its Major Active Metabolite ortho-OH-Atorvastatin in Aging People Living with HIV.
Courlet P, Decosterd LA, Alves Saldanha S, Cavassini M, et al · · 2020 · cited 5× · PMID 32281059 · DOI 10.1007/s40262-020-00876-0
Verify or expand the search:
- PubMed search for NCT03515772
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03515772 (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 Centre Hospitalier Universitaire Vaudois
- Last refreshed: 28 July 2020
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/NCT03515772.
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