Clinical trials: Infection, Human Immunodeficiency Virus I
HIV
A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials
The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants.
- Trial name
- NCT02187107
- Testing
- TMC114, rtv
- Where
- 11 sites in Australia, Austria and 6 more
- Volunteers
- 52 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection
AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To determine whether the experimental drug recombinant CD4 (rCD4), which is produced through genetic engineering technology, is safe and…
- Trial name
- NCT00000984
- Testing
- CD4 Antigens
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infection, Human Immunodeficiency Virus
Dolutegravir Renal Impairment Study
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV Healthcare LLC.
- Trial name
- NCT01353716
- Testing
- Dolutegravir 50 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infections, Human Immunodeficiency Virus and Herpesviridae
GSK1349572 Drug Interaction Study With Fosamprenavir/Ritonavir
GSK1349572 is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV HealthcareLLC.
- Trial name
- NCT01209065
- Testing
- GSK1349572, Fosamprenavir, Ritonavir
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein…
- Trial name
- NCT00369031
- Testing
- Human Immunodeficiency Virus glycoprotein 140 (vaccine), HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant, Labile Toxin mutant LTK63 adjuvant
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
HIV Infections
Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with > 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose.
- Trial name
- NCT00000977
- Testing
- gp160 Vaccine (MicroGeneSys)
- Where
- 2 sites in United States
- Volunteers
- 52 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Influenza
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents.
- Trial name
- NCT00091702
- Testing
- Cold-adapted live attenuated influenza vaccine (FluMist), Inactivated influenza vaccine (IAIV)
- Where
- 61 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
TMC114-TiDP3-C182 - A Study to Compare the Oral Bioavailability of a 800 mg Prototype Tablet Formulation of Darunivar (DRV) to That of the 400 mg Commercial Tablet Formulation in the Presence of Low Dose Ritonavir, Under Fasted and Fed Conditions
The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that following administration of two 400 mg commercial…
- Trial name
- NCT01052883
- Testing
- DRV commercial formulation/ DRV new formulation/ rtv 100mg tab
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).
- Trial name
- NCT03208231
- Testing
- VRC01, Combination Antiretroviral Therapy (cART)
- Where
- 7 sites in Botswana, Brazil and 2 more
- Volunteers
- 61 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy, HIV Infection
Safety and Anti-HIV Activity of Capravirine Alone and in Combination With Other Anti-HIV Drugs
This 2-part study will test the safety and anti-HIV activity of capravirine alone, and the safety, anti-HIV activity, and drug interactions of capravirine combined with other anti-HIV drugs.
- Trial name
- NCT00005673
- Testing
- Capravirine
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients
To evaluate the safety of single and multiple doses (28 daily doses) of 9-[2-(R)-[[bis[[(isopropoxycarbonyl)- oxy]methoxy]phosphinoyl]methoxy]propyl]adenine fumarate (PMPA) prodrug administered orally to HIV-infected patients.
- Trial name
- NCT00002396
- Testing
- Tenofovir disoproxil fumarate
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Gilead Sciences
HIV Infections
A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in HIV-infected persons. To determine the proportion of study participants immunized who develop new specificities or increased levels of…
- Trial name
- NCT00001060
- Testing
- HIV-1 C4-V3 Polyvalent Peptide Vaccine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infection, Human Immunodeficiency Virus I, HIV Infection
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.
- Trial name
- NCT00242840
- Testing
- No intervention; Observational study
- Where
- 7 sites in United States, Italy
- Volunteers
- 20 people
- Sponsor
- ViiV Healthcare
HIV Infections
The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
To determine the safety and tolerability of hydroxyurea at two doses alone and in combination with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus hydroxyurea plus ddI, as measured by plasma…
- Trial name
- NCT00001074
- Testing
- Hydroxyurea, Didanosine
- Where
- 18 sites in United States
- Volunteers
- 140 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV I Infection, Adiposity
Assessing the Impact of INSTI to PI Switch on Insulin Sensitivity and Fat Metabolism
A substudy of TMC114FD2HTX4004 that will perform glucose tolerance testing, adipose testing and MRI scan at baseline, 12 and 24 weeks post switch of ART medications.
- Trial name
- ADIPOSITY (NCT04675255)
- Testing
- Frequently sampled glucose tolerance testing, abdominal subcutaneous adipose tissue biopsy, MRI scan to assess intrahepatic triglyceride content
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Washington University School of Medicine
HIV I Infection
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal…
- Trial name
- NCT00659789
- Testing
- Vacc-4x, Sterile water
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 137 people
- Sponsor
- Bionor Immuno AS
HIV Infections
A Study of Tucaresol in HIV-Infected Patients Who Are Taking Other Anti-HIV Drugs
The purpose of this study is to see if it is safe to give tucaresol to HIV-infected patients who are taking combination anti-HIV therapy (HAART).
- Trial name
- NCT00006209
- Testing
- Tucaresol
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Aaron Diamond AIDS Research Center
Healthy Volunteer
Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection.
- Trial name
- NCT03878121
- Testing
- Ad4-Env145NFL, Ad4-Env150KN, VRC-HIVRGP096-00-VP (Trimer 4571) with alum
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)
The purpose of this Phase I, open-label, single sequence drug-drug interaction trial in human immunodeficiency virus-type 1 infected patients is to investigate the potential interaction between steady-state nevirapine (NVP) 200…
- Trial name
- NCT00910806
- Testing
- TMC207; nevirapine
- Where
- South Africa
- Volunteers
- 16 people
- Sponsor
- Tibotec BVBA
HIV Infections, TB
A Study of MVA85A, in Asymptomatic Volunteers Infected With TB, HIV or Both
This study is designed to evaluate the safety of MVA85A in asymptomatic volunteers in South Africa who are infected with M.tb, HIV or both.
- Trial name
- NCT00480558
- Testing
- MVA 85A
- Where
- South Africa
- Volunteers
- 48 people
- Sponsor
- University of Oxford