Clinical Trials Logo

HIV-1 Infection clinical trials

View clinical trials related to HIV-1 Infection.

Filter by:

NCT ID: NCT03875209 Not yet recruiting - HIV-1-infection Clinical Trials

A Phase I Study of the Safety, Pharmacokinetics and Antiviral Activity of the Bispecific Antibody 10E8.4/iMab

Start date: April 5, 2019
Phase: Phase 1
Study type: Interventional

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 protect macaques from infection, and the presence of anti-HIV antibodies was the only positive correlate of protection in an HIV vaccine efficacy trial (RV144 trial). HIV neutralizing antibodies also have the potential to alter the course of HIV infection in humans. Therefore, these antibodies might be useful to both prevent and treat HIV-1 infection. This is a phase 1 dose escalating clinical trial to evaluate the safety, tolerability, pharmacokinetics and the antiretroviral effects of a novel bispecific monoclonal antibody 10E8.4/iMab in HIV-infected and HIV-uninfected individuals. The study will be conducted as a multi-center study at the Columbia University Medical Center in New York City and the Orlando Immunology Center in Orlando FL.

NCT ID: NCT03866759 Not yet recruiting - HIV Infections Clinical Trials

Prospective Observational Cohort HIV & STI Study in Europe

Start date: March 2019
Phase:
Study type: Observational

Investigators are sponsoring the Multicenter human immunodeficiency virus (HIV) and sexually transmitted infections Prevention Network Study (STIPnet) which is funded by Janssen, Pharmaceutical Companies of Johnson & Johnson. STIPnet study is a prospective observational cohort study aiming to determine the incidence and point prevalence of HIV infection and the most common sexually transmitted infections (STIs) in individuals with sexual risk behavior. In addition, investigators will examine whether individuals at risk for HIV and STI infections would retain in such a study (retention rate) and would be willing to participate in potential HIV and STI prevention trials (willingness to participate).

NCT ID: NCT03859739 Not yet recruiting - HIV-1 Infection Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8558 Monotherapy in Anti-Retroviral-Naïve HIV-1 Infected Participants (MK-8558-002)

Start date: April 11, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8558 monotherapy in anti-retroviral-naïve HIV-1 infected participants. The primary hypothesis is that at a dose that exhibits an acceptable safety and tolerability profile, MK-8558 has superior anti-retroviral activity compared to historical placebo data.

NCT ID: NCT03848325 Not yet recruiting - Inflammation Clinical Trials

Poor Sleep and Inflammation in HIV-Infected Adults

SASH
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

People living with HIV (PLWH) often have poor sleep, which may put them at a higher risk for many chronic diseases, including cardiovascular disease. One of the mechanisms by which this may occur is via chronic inflammation and endothelial dysfunction. Adenosine plays an important role in sleep homeostasis, with levels increasing in the CSF in response to sleep deprivation and falling with sleep. Peripherally, adenosine, via its signaling pathway, plays an important role in immunoregulation by suppressing the inflammatory response. PLWH, even on antiretroviral therapy, have suppressed peripheral adenosine levels which are predictive of adverse cardiovascular outcomes. The hypothesis underlying this study is that acute sleep deprivation in PLWH does not result in a compensatory increase in extracellular adenosine and its signaling peripherally, and this failure to appropriately compensate, leads to an increase in systemic inflammation and endothelial dysfunction.

NCT ID: NCT03844386 Recruiting - HIV-1 Infection Clinical Trials

Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults

M&M
Start date: March 2019
Phase: Phase 1
Study type: Interventional

This is a double blind, randomized, placebo-controlled, parallel design, study in which 27 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3), MVA.tHIVconsv4 (M4), M3+M4 combined, or placebo. Participants will be randomized 8:8:8:3 to one of four study arms, and receive study treatment or placebo at Day 0. Each enrolled participant will complete the study in approximately 33.5 weeks (8.4 months). The purpose of this study is to find out: - If it is safe for people to receive injections of two investigational HIV vaccines, called MVAtHIVconsv3 and MVAtHIVconsv4 alone or in combination. - If giving participants these vaccine doses will increase their immune system's ability to kill HIV virus.

NCT ID: NCT03837756 Not yet recruiting - HIV-1-infection Clinical Trials

Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV

TITAN
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety and efficacy of lefitolimod and 3BNC117/10-1074 in HIV-1-infected individuals on ART and during ATI as intervention to reduce the HIV-1 reservoir

NCT ID: NCT03837015 Not yet recruiting - HIV-1-infection Clinical Trials

Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women

Start date: March 2019
Phase: Phase 1
Study type: Interventional

This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.

NCT ID: NCT03835546 Completed - Clinical trials for Cognitive Impairment

Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

ARBRE
Start date: October 26, 2015
Phase:
Study type: Observational

The ARBRE Study is an observational prospective trial aimed at investigating the impact of the therapy initiation with INTIs on brain outcomes according to the time of therapy initiation. Three study arms are considered: 1) Early treated HIV-1 infected patients (<3 months since estimated date of infection), 2) Regularly treated HIV-1 infected patients (>6 months since estimated date of infection), 3) Matched seronegative control group. Study assessments will be performed at baseline, 1 month and 12 months. Study assessments will comprise comprehensive evaluation of brain outcomes. They will include cognitive functioning, neuroimaging parameters, and functional outcomes.

NCT ID: NCT03834909 Not yet recruiting - Pregnancy Clinical Trials

Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)

Start date: June 2019
Phase: Phase 1
Study type: Interventional

This trial is a prospective, multi-center, randomized comparison study of 2 Pre-Exposure Prophylaxis (PrEP) pharmacokinetic (PK) dosing regimens from 1st trimester through 12 weeks following delivery (postpartum) to achieve study objectives which include PK, safety monitoring for maternal and fetal/infant safety signals, and adherence.

NCT ID: NCT03825536 Not yet recruiting - HIV-1-infection Clinical Trials

Effect of Methamphetamine on Residual Latent HIV Disease Study

EMRLHD
Start date: March 1, 2019
Phase: Phase 4
Study type: Interventional

The most commonly used illicit stimulant in HIV-infected individuals is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation. A challenge in achieving worldwide HIV eradication is targeting specific marginalized populations who are most likely to benefit from an HIV cure but possess poorer immune responses. For this study, HIV+ infected ART-suppressed individuals with no prior history of MA use disorder will be administered oral methamphetamine (the maximum FDA approved daily dose for the treatment of childhood obesity) to determine the effects of short-term MA exposure on residual virus production, gene expression, and inflammation. Measures of MA exposure in urine and serum will then be associated with residual virus production, gene expression, cell surface immune marker protein expression, and systemic markers of inflammation. The clinical trial data will generate advanced gene expression and immunologic data to identify potential novel targets for reversing HIV latency, reducing inflammation, and personalizing future therapies in HIV+ individuals who use MA.