Clinical trials: Controlled Human Infection
Hepatitis C
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy.
- Trial name
- PROMISE (NCT01281839)
- Testing
- TMC435, Peginterferon alpha-2a (PegIFN alpha-2a), Ribavirin (RBV)
- Where
- 68 sites in United States, Australia and 11 more
- Volunteers
- 394 people
- Sponsor
- Janssen R&D Ireland
Healthy
A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine
This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent…
- Trial name
- MI-MA205 (NCT00873912)
- Testing
- Monovalent influenza virus vaccine
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Influenza
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening.
- Trial name
- NCT03969212
- Testing
- Baloxavir Marboxil
- Where
- 142 sites in United States, Bulgaria and 14 more
- Volunteers
- 4,138 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults
Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities.
- Trial name
- NCT03784079
- Testing
- GSK3640254
- Where
- 23 sites in United States, France and 4 more
- Volunteers
- 34 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
- Trial name
- INTENSE (NCT00487188)
- Testing
- Enfuvirtide, Highly active antiretroviral treatment (HAART)
- Where
- 39 sites in United States, Canada and 8 more
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
Respiratory Tract Infection
A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may…
- Trial name
- NCT03572062
- Testing
- Formulation A, Formulation B, Formulation C
- Where
- 16 sites in United States, Australia
- Volunteers
- 317 people, healthy volunteers welcome
- Sponsor
- Pfizer
Influenza
Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1.
- Trial name
- NCT01773928
- Testing
- Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified), VCIV manufactured with the current manufacturing process (VCIV current), Fluzone®, licensed trivalent influenza vaccine (TIV)
- Where
- 20 sites in United States
- Volunteers
- 1,928 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Infections, Papillomavirus
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in…
- Trial name
- NCT01190189
- Testing
- GSK580299 (Cervarix)
- Where
- 28 sites in United States, Canada
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Common Cold
Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.
- Trial name
- NCT00762476
- Testing
- 3804-250A, 3804-291
- Where
- 2 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- The Dial Corporation
Adult Primary Liver Cancer, Hepatitis C Infection
Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection
This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients with chronic hepatitis C infection.
- Trial name
- NCT00513461
- Testing
- S-adenosyl-L-methionine disulfate p-toluene-sulfonate, laboratory biomarker analysis, immunoenzyme technique
- Where
- 5 sites in United States
- Volunteers
- 110 people
- Sponsor
- Chao Family Comprehensive Cancer Center
Hepatitis C, Chronic
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons.
- Trial name
- NCT01054573
- Testing
- Telaprevir, pegylated interferon (Peg-IFN) alfa-2a, ribavirin (RBV)
- Where
- 48 sites in United States, Australia and 13 more
- Volunteers
- 90 people
- Sponsor
- Janssen Infectious Diseases BVBA
Meningococcal Meningitis, Human Papillomavirus Infection
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
- Conditions
- Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis, Tetanus
- Trial name
- NCT00518180
- Testing
- Novartis Meningococcal ACWY Conjugate Vaccine, Tdap Vaccine
- Where
- Costa Rica
- Volunteers
- 1,620 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV-1 Infection
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
The primary objectives of this study are: Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day…
- Trial name
- NCT03739866
- Testing
- Lenacapavir, B/F/TAF, TAF
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Gilead Sciences
HIV -1 Infection, HIV Infections
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
The purpose of this study is: 1. To assess the antiviral activity of PRO 140 2. To assess the safety and tolerability of PRO 140 3. To generate additional PK, PD and safety data of PRO 140
- Trial name
- NCT00642707
- Testing
- PRO 140 (humanized monoclonal antibody to CCR5)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- CytoDyn, Inc.
Human Papillomavirus Infection
Lubricant Investigation in Men to Inhibit Transmission of HPV Infection
The LIMIT-Study is a placebo-controlled, double-blinded randomized controlled trial designed to explore the efficacy of a carrageenan-based lubricant as a topical microbicide for preventing HPV acquisition.
- Trial name
- LIMIT-HPV (NCT02354144)
- Testing
- Carrageenan-based gel, Control gel
- Where
- Canada
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- McGill University
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
This 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.
- Trial name
- NCT05393271
- Testing
- VH4011499, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Rubella, Mumps
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first…
- Conditions
- Rubella, Mumps, Measles, Measles-Mumps-Rubella Vaccine
- Trial name
- NCT00861744
- Testing
- GSK Biological's investigational vaccine 209762, M-M-R® II (Merck and Co), Varivax®
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 1,259 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria,Falciparum, Controlled Human Malaria Infection
Safety and Efficacy of NF135 CPS Immunization
This is an open label, randomized, controlled clinical trial. The primary aim of this project is to determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxis against homologous and…
- Conditions
- Malaria,Falciparum, Controlled Human Malaria Infection, Immunization; Infection
- Trial name
- CPS135 (NCT03813108)
- Testing
- CPS-immunization, malaria challenge infection, P. falciparum NF135.C10, malaria challenge infection, P. falciparum NF54
- Where
- Netherlands
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Cervical Cancer, Vulvar Cancer
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and…
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts
- Trial name
- NCT00543543
- Testing
- Comparator: GARDASIL, Experimental: V503
- Volunteers
- 14,840 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection
- Trial name
- NCT00546715
- Testing
- Daclatasvir
- Where
- 7 sites in United States
- Volunteers
- 95 people
- Sponsor
- Bristol-Myers Squibb