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NCT02076386: DOL-ART
A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany
trial testing Dolutegravir in Infection, Human Immunodeficiency Virus in 411 participants. Completed in 5 July 2017.
5 July 2017
Quick facts
| Lead sponsor | ViiV Healthcare |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 411 |
| Start date | 4 March 2014 |
| Primary completion | 5 July 2017 |
| Estimated completion | 5 July 2017 |
| Sites | 38 locations across Germany |
Drugs / interventions tested
- Dolutegravir (DOLUTEGRAVIR) — full drug profile →
Conditions studied
- Infection, Human Immunodeficiency Virus — all drugs for Infection, Human Immunodeficiency Virus →
Sponsor
ViiV Healthcare — full company profile →
Who can join
18 and older, any sex, with Infection, Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. The primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany. The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir, due to death, withdrawal of consent, lost to follow-up).
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 NCT02076386
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05652478 — Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study · Phase 2 · recruiting
- NCT06805656 — Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals · Phase 2 · not yet recruiting
- NCT05979311 — A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Ora · Phase 3 · active not recruiting
Other recruiting trials for Infection, Human Immunodeficiency Virus
Currently open trials in the same condition.
- NCT02951052 — Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpiv · Phase 3 · active not recruiting
Other ViiV Healthcare trials
Trials by the same sponsor.
- NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative · Phase 3 · not yet recruiting
- NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
- NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
- NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir · Phase 1 · active not recruiting
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 NCT02076386 (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 ViiV Healthcare
- Last refreshed: 13 August 2018
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/NCT02076386.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing