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HIV-1 Infection clinical trials

View clinical trials related to HIV-1 Infection.

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NCT ID: NCT03729778 Recruiting - HIV Infections Clinical Trials

Impact of HIV-1 and Aging on Mucosal Vaccine Responses

Start date: January 18, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to learn more about both HIV-1 infection and advancing age, alone and in combination, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.

NCT ID: NCT03729752 Recruiting - HIV-1-infection Clinical Trials

PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

Start date: November 1, 2018
Phase: Phase 1
Study type: Interventional

This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR imaging in HIV infected individuals and healthy volunteers. Imaging data will be obtained from up to four static PE-MR images in order to determine dosimetry and temporal tissue uptake/tissue distribution of 89Zr-DFO-VRC01. This is not a treatment study of the biological activity of 89Zr-DFO-VRC01 to impact HIV persistence.

NCT ID: NCT03719664 Not yet recruiting - HIV-1-infection Clinical Trials

Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects

ABL
Start date: November 2018
Phase: Phase 2
Study type: Interventional

The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection.

NCT ID: NCT03709355 Not yet recruiting - HIV-1-infection Clinical Trials

Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs

Start date: October 2018
Phase: Phase 1
Study type: Interventional

The study assesses PK and safety of other drugs, such as some antibiotics, proton pump inhibitors, statins, and combined oral contraceptives when co-administered with Elpida®

NCT ID: NCT03706950 Recruiting - HIV-1-infection Clinical Trials

Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART

Start date: March 15, 2018
Phase:
Study type: Observational

This post-registration observational study is designed to monitor the safety parameters and efficacy of Elpida® in actual practice in the first-line treatment of HIV-1 infected patients on the background of the standard baseline ART.

NCT ID: NCT03706924 Completed - HIV-1-infection Clinical Trials

Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects

Start date: June 1, 2018
Phase: Phase 1
Study type: Interventional

Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. The study will also assess safety profile of study drugs.

NCT ID: NCT03706911 Not yet recruiting - HIV-1-infection Clinical Trials

Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects

Start date: December 2018
Phase: Phase 1
Study type: Interventional

This is a study to evaluate safety, tolerability and pharmacokinetics of VM-1500A-LAI single and multiple ascending doses in healthy subjects. The study will be conducted in 1 investigational site in Russia in healthy volunteers.

NCT ID: NCT03706898 Recruiting - Hepatic Impairment Clinical Trials

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs

Start date: October 1, 2018
Phase: Phase 1
Study type: Interventional

This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the impact of food intake and drug-drug interactions in case of Co-administration with other antiviral drugs in healthy subjects.

NCT ID: NCT03705169 Not yet recruiting - HIV-1-infection Clinical Trials

Pharmacokinetics of SAR441236

Start date: October 31, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against the human immunodeficiency virus (HIV).

NCT ID: NCT03683524 Not yet recruiting - HIV-1 Infection Clinical Trials

Efficacy and Safety of a Simplification Treatment Based on Dolutegravir and Darunavir / Cobicistat vs Usual Treatment in Suppressed HIV-1-infected Patients With Multidrug Resistance.

Start date: October 2018
Phase: Phase 4
Study type: Interventional

The availability of antiretroviral therapy has led to a reduction in morbidity and mortality in patients with chronic HIV infection. The treatment, however, is not free of side effects, has potential interactions with other medications, is expensive and can be complex, especially in those patients who are very experienced and with mutations that give them resistance to multiple drugs. For this reason, the development of simplification strategies that avoid unnecessary exposure to antiretroviral agents remains of great interest. This is a simplification study, in which the investigators try to evaluate that with less medication the investigator can maintain the same virological control of the disease. This would mean a lower burden of medication for patients, facilitating its administration and reducing the number of unwanted side effects. Specifically, the investigators intend to evaluate the treatment with Darunavir / cobicistat plus Dolutegravir as a simplification strategy, since both drugs are taken once a day, have a powerful antiviral activity, even against antiretroviral resistant viruses, and are among the best tolerated (with fewer side effects). The results reported in some observational studies suggest that two-drug therapy (bitherapy) as a simplification strategy could also be safe and effective, however, as far as the investigators know, there are no data and clinical trials that specifically evaluate darunavir / cobicistat plus dolutegravir as a strategy of simplification.