ViiV Healthcare

This sponsor has funded 26 studies across 51 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
7597 Finalised EU RMP category 3 A Prospective Observational Cohort Study to Monitor and Compare the Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving... Yes Yes
13473 Finalised Not included in RMP Descriptive Analysis of Neuropsychiatric Diagnoses in Patients taking Dolutegravir in the OPERA® Observational Database (205846) Yes Yes
13840 Ongoing Not included in RMP Prenatal Exposure to Dolutegravir and Pregnancy and Neonatal Outcomes: Data from Antiretroviral Pregnancy Registry (206242) Yes No
14290 Finalised Not included in RMP Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing (206206) Yes Yes
16321 Finalised Not included in RMP Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration... Yes Yes
16324 Finalised Not included in RMP Abacavir Use and Risk for Myocardial Infarction and Coronary Artery Disease: Meta-analysis of Data from Clinical Trials (207263) Yes Yes
17919 Finalised Not included in RMP Abacavir Usage Patterns and Trends in Hypersensitivity Reactions (HSR) in the EuroSIDA cohort (206307) Yes Yes
18543 Finalised Not included in RMP Rates of Suspected Hypersensitivity Reaction in HIV infected Adult treatment populations screened HLA-B*5701 negative prior to commencing Abacavir... Yes Yes
18709 Finalised Not included in RMP Post-marketing safety analyses for multiple marketed products in collaboration with the D:A:D study (206247) Yes Yes
19875 Finalised Not included in RMP Comparison of Dolutegravir Effectiveness vs. Other Anchor Agent Effectiveness among Hepatitis C Virus Co-infected patients in the OPERA® Observational... Yes Yes
22231 Finalised Not included in RMP A Comprehensive Assessment of Adverse Events and Overall Safety Profile in HIV Positive Patients Treated with Dolutegravir as Compared to Other... Yes Yes
22915 Finalised EU RMP category 3 DOLOMITE EPPICC Study: Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric... Yes Yes
24237 Ongoing EU RMP category 3 DOLOMITE NEAT ID Network Study: A prospective, multi-site observational study to define the safety and effectiveness of Dolutegravir use in HIV... Yes No
24473 Finalised Not included in RMP Development of AntiRetroviral Therapy in Africa (DART) study post hoc safety data analysis comparing safety outcomes of study participants with... Yes Yes
24990 Finalised EU RMP category 3 ‘COMBINE-2’: Real-world evidence for effectiveness of Two Drug Regimen, Antiretroviral therapy with integrase inhibitors plus a reverse transcriptase... Yes Yes
26602 Finalised Not included in RMP Dolutegravir use and incidence of prediabetes and type 2 diabetes mellitus (209368) Yes Yes
26866 Finalised Not included in RMP Dolutegravir Use and Predictors of CNS events: Meta-analysis of Data from Phase III/IIIb Clinical Trials Yes Yes
27523 Finalised Not included in RMP An Evaluation of Weight Gain in Patients Treated with Dolutegravir vs. Other Core Agents (208943) Yes Yes
27718 Finalised Not included in RMP An Evaluation of the Safety of Lamivudine in HIV Positive Patients with Renal Impairment (208948) Yes Yes
28753 Finalised Not included in RMP An evaluation of weight gain in patients treated with dolutegravir and other core agents (209025) No No
32268 Finalised Not included in RMP A multi- site observational study to assess safety and effectiveness of prenatal exposure to Dolutegravir in HIV positive pregnant women (212976) Yes No
42556 Ongoing EU RMP category 1 Drug Utilization, Adherence, Effectiveness and Resistance: A Prospective Observational Cohort Study in People living with HIV (PLWH) initiating ARV... Yes No
42609 Ongoing EU RMP category 3 C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen - A Prospective Cohort Study to Monitor Effectiveness, Adherence and Resistance (215160) Yes No
45568 Ongoing EU RMP category 3 A prospective observational cohort study to monitor for hepatotoxicity and regimen discontinuation due to liver related adverse events among People... No No
45685 Ongoing EU RMP category 3 Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir: Data from The Antiretroviral Pregnancy Registry (APR) (215325) No No
45777 Ongoing EU RMP category 3 Pregnancy and Neonatal Outcomes following Prenatal Exposure to Cabotegravir Long Acting (CAB LA): Data from the European Pregnancy and Paediatric HIV... No No

PAS by Risk Management Plan (RMP) requirement

ViiV Healthcare

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.