An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain
Herpes ZosterNeuralgia6 moreThis study is an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114
The Safety and Effectiveness of Ribavirin in the Early Stages of HIV-Infection
HIV InfectionsThe objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV disease as defined by CDC classification, and whether the dosage regimen is safe and tolerable in these subjects.
Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy...
HIV InfectionsQuestion arises as to whether this new treatment "Cabotegravir-rilpivirineactually" improves patient satisfaction and whether it is well suited to everyone, especially those with a history of irregular follow-up. Also, inconvenience of two intramuscular injections every two months and constraint of care organization could represent a barrier to treatment for some patients.
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK)...
HIV InfectionsThis FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD) and Part 2 will investigate multiple ascending doses (MAD). Part 3 will investigate single dose of a new formulation of VH4011499. The transition from SAD to MAD will be based on the assessment of the Safety and Dose Escalation Committee.
Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients...
HIV InfectionsPrimary Objectives 1.Evaluation of safety and tolerability after repeated administration of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy Secondary Objectives Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters. Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients not receiving antiretroviral therapy. Evaluation of the immunogenicity of lipovirtide for injection.
Leaving Nobody Out
HIV InfectionsEstablished recruitment methods will be used to recruit participants. The study will be non-blinded. Eligibility will be checked and consent taken by a delegated study clinician. Participants will attend a 30 minute virtual individual semi-structured interview. Additionally, all patients attending an appointment within Harrison Wing will be invited to complete an anonymous, self-administered survey on attitudes towards participation in HIV clinical studies.
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in...
HIV-1 InfectionThe principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.
HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection
Human Immunodeficiency VirusHepatitis C1 moreThis is an prospective open label pilot study conducted over 32 weeks. A total of 25 eligible participants who are infected with HCV and HIV will be recruited from 2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill University Health Centre) This study is investigating the effectiveness of a combination of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF STR) for HIV treatment and Harvoni for HCV treatment. This study will assess the effect that the study drug has on the metabolism of sugar, the changes in fat in the bloodstream, and other metabolic changes. Metabolism is the process your body uses to get or make energy from the food you eat. This study may provide information on the impact of liver fibrosis (scarring of liver tissues) on metabolic changes before, during and after HCV antiviral therapy. Drug-drug interactions (DDI) between E/C/F/TAF and LPV-SOF have been well evaluated and no clinically significant interactions have been identified. A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be particularly beneficial because of its: favorable side effect profile once daily STR formulation known DDI profile with LPV-SOF neutral effect on liver fibrosis improved kidney and bone safety profile with the use of TAF Conduct of this study is justified as it: Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and HCV using well tolerated medications with an excellent safety profile and known DDI profile. Provides additional safety data for TAF in the HIV-HCV co-infected population. Quantifies adherence and identifies obstacles to full adherence in this population. There is a paucity of data related to DAA adherence in licensing studies. Provides real-world safety and efficacy data to support the public funding for LPV-SOF DAA therapy in HIV-HCV co-infected populations. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance in HIV-HCV co-infection As a pilot study, the information gathered will inform the feasibility of future clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.
Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy...
HIV InfectionsThe study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.
Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load
Alcohol DrinkingHIVThe purpose of this study is to compare the effectiveness of two interventions [a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention], against each other and with an assessment-only control, in improving both alcohol- and HIV-related outcomes, among hazardous and heavy drinking HIV-infected antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.