Clinical trials: Antivirals/HIV
HIV-1-infection
10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults
Many HIV-infected individuals mount a broad neutralizing serologic response 2-3 years after infection. Broadly neutralizing antibodies might play an important role in protection from acquisition of HIV infection because they can…
- Trial name
- NCT03875209
- Testing
- 10E8.4/iMab
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- David Ho
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or…
- Trial name
- NCT04212091
- Testing
- PGT121.414.LS, VRC07-523LS
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS, Antiviral Toxicity
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear.
- Conditions
- HIV/AIDS, Antiviral Toxicity, Antiviral Drug Adverse Reaction, Mitochondrial Alteration
- Trial name
- UCLACAREMITO (NCT03251144)
- Testing
- Switch to E/C/FTC/TAF daily
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV Infections
A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGDM1400 and PGT121 and VRC07-523LS mAbs for HIV prevention and therapy.
- Trial name
- NCT03205917
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
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)
Healthy
The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers
Infection by both HIV and hepatitis C virus (HCV)is frequent due to similar transmission modes. Near 20% of people living with HIV are also infected by HCV.
- Trial name
- NCT01627717
- Testing
- Maraviroc (5 days), Maraviroc and boceprevir (14 days)
- Where
- Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
HIV-1-infection, Hepatitis C, Chronic
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy
The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current…
- Conditions
- HIV-1-infection, Hepatitis C, Chronic, Methadone Dependence, Opioid Dependence
- Trial name
- NCT03549312
- Testing
- Genvoya, Epclusa, Biktarvy
- Where
- Canada
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Saskatchewan Health Authority - Regina Area
HIV -1 Infection
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV).
- Trial name
- NCT07392372
- Testing
- BNT351
- Where
- 6 sites in United States, Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
HIV Infections
DDI HV (ATV - Merck)
The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg…
- Trial name
- NCT00518297
- Testing
- Raltegravir, Atazanavir, Atazanavir + Raltegravir
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Pregnancy, HIV
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception
The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower levels of a birth control medication called norethindrone.
- Conditions
- Pregnancy, HIV, AIDS
- Trial name
- NET (NCT01667978)
- Testing
- Norethindrone acetate
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Southern California
HIV, Antiviral Agents
Antiviral Long Acting Drugs Landing in People Living With HIV
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for…
- Trial name
- ALADDIN (NCT06468995)
- Testing
- Surveys completion, Home administration of CAB+RPV, Hospital administration of CAB+RPV
- Where
- Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele
HIV Infections
A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
To evaluate the degree and sequence of immunologic enhancement and the cellular resistance to certain infections after a single dose of atvogen (ampligen).
- Trial name
- NCT00001000
- Testing
- Ampligen
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Study of Safety and Pharmacokinetics in Healthy Volunteers and Safety, Tolerability and Antiviral Activity of VM-1500 in Patients With Human Immunodeficiency Virus-1 Infection
A combined Phase Ib and IIa randomized, placebo-controlled, double-blind study of VM-1500 in healthy subjects and in patients with HIV-1 infection that are antiretroviral therapy naïve.
- Trial name
- NCT02485509
- Where
- Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Viriom
Antivirals/HIV
Drug Interaction Study
The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)
- Trial name
- NCT00646776
- Testing
- Rifabutin, Rifabutin + Atazanavir + Ritonavir
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
HIV Infection
Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.
- Trial name
- NCT02960581
- Testing
- PGT121 3mg/kg IV, PGT121 10mg/kg IV, PGT121 30mg/kg IV
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
HIV/AIDS
A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.
- Trial name
- NCT03721510
- Testing
- PGT121 + VRC07-523LS, PGT121 + VRC07-523LS + PGDM1400
- Where
- 3 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
HIV Infections
Phase I/II, Open-Label Trial of Three Monoclonal Antibodies
Monoclonal antibody infusions will prevent rebound of viremia in well-suppressed HAART-treated individuals who began therapy during acute and early HIV-1 infection.
- Trial name
- NCT00219986
- Testing
- Potent HAART during acute or early HIV-1 infection
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
HIV Infections
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
- Trial name
- NCT04592315
- Testing
- Lipovirtide Injection
- Where
- China
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Shanxi Kangbao Biological Product Co., Ltd.
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion…
- Trial name
- NCT03928821
- Testing
- PGT121, PGDM1400, 10-1074
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)