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HIV-1 Infection clinical trials

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NCT ID: NCT02603120 Completed - HIV-1 Infection Clinical Trials

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

Start date: November 11, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

NCT ID: NCT02603107 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Start date: November 20, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

NCT ID: NCT02600819 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

Start date: December 14, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).

NCT ID: NCT02592174 Completed - HIV-1 Infection Clinical Trials

Prevalence, Characteristics and Risk Factors of HIV-Associated Neurocognitive Disorders in Subjects Between the Ages of 55 and 70 Years: An Exposed/Unexposed Cross Sectional Study

HAND55-70
Start date: January 26, 2016
Phase: N/A
Study type: Interventional

The primary objective is to measure the prevalence of according to the Frascati classification in a HIV-infected population aged between 55 and 70 years (exposed group) and to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on age, gender, geographical origin and socioprofessional category.

NCT ID: NCT02590354 Completed - HIV-1 Infection Clinical Trials

Analytical Treatment Interruption in HIV Positive Patients

ISALA
Start date: January 25, 2016
Phase: N/A
Study type: Interventional

HIV-1 infected patients with normal peripheral blood CD4+ T-cell counts and undetectable viral load will be recruited in four Belgian HIV reference centers. Selected patients will undergo a two-step screening in which a viral reservoir measurement will be performed and among those with a very low viral reservoir an analytical treatment interruption of their longstanding antiretroviral therapy (ART). There is no randomization foreseen. Patients will receive an intense clinical and laboratory follow-up during 48 weeks followed by 12 weeks post intervention.

NCT ID: NCT02588586 Completed - HIV-1 Infection Clinical Trials

A Study of the Safety and Antiretroviral Activity of 3BNC117

Start date: October 2015
Phase: Phase 2
Study type: Interventional

This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART, and its safety during a brief analytical interruption of antiretroviral therapy.

NCT ID: NCT02582684 Completed - HIV-1 Infection Clinical Trials

Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients

Start date: December 8, 2015
Phase: Phase 2
Study type: Interventional

This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV. DTG is a type of HIV medicine called an integrase inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended regimens along with a third active drug. Since some HIV medicines have side effects and are costly, there is interest in whether HIV can be successfully controlled with fewer than three HIV drugs.

NCT ID: NCT02581202 Completed - HIV-1 Infection Clinical Trials

The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation

SIMPLE
Start date: December 21, 2015
Phase:
Study type: Observational

This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.

NCT ID: NCT02578706 Completed - HIV-1 Infection Clinical Trials

Targeting Platelets in Chronic HIV Infection

Start date: October 2015
Phase: Phase 2
Study type: Interventional

Advances in antiretroviral therapy (ART) have resulted in increased survival of the HIV-infected population; however, this gain in longevity is associated with an increased risk of cardiovascular disease (CVD). Although ART and traditional risk factors contribute to CVD in this population, heightened markers of immune activation, inflammation, and coagulation independently predict morbidity and mortality, suggesting that dysregulation of these systems plays a significant role in the increased risk of CVD. The investigators believe that platelet activation is an important driver in HIV-associated immune activation, inflammation, and coagulation, leading to an increased CVD pathophysiology and risk. Platelets initiate thrombus formation and also play a key role in vascular inflammation by releasing pro-inflammatory mediators and cross-talking with other relevant cell types including leukocytes. Researchers have described platelet hyperreactivity in chronic HIV infection. Importantly, the investigators demonstrated that one week of anti-platelet therapy (aspirin) decreased platelet activation and immune activation, with an improved trend in inflammation and immune parameters. The overall hypothesis is that platelet activation is a major driver of immune activation, inflammation, and thrombosis in ART-treated HIV infected patients. The purpose of the proposed proof-of-concept study is to understand the mechanism(s) by which anti-platelet therapy improves immune and inflammatory parameters in chronic HIV infection. To test this, the immune modulating and anti-inflammatory effects of 24 weeks of the anti-platelet drug aspirin as compared to the anti-platelet drug clopidogrel will be evaluated. Given their different mechanisms of action and inhibitory potency, the investigators can differentiate whether the potential benefits are mediated via inhibition of arachidonic acid (aspirin) or inhibition of ADP (clopidogrel) or by the antithrombotic activity. A secondary goal is to perform multidimensional assays of platelet activity and thrombogenicity alongside immune activation assays and careful assessments of traditional risk factors and medication regimens, to understand which parameters are highly associated with thrombogenicity.

NCT ID: NCT02566707 Terminated - HIV-1 Infection Clinical Trials

Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen

PRADAII
Start date: August 2015
Phase: Phase 2
Study type: Interventional

During the past years the treatment of HIV-1 infection has transformed towards chronic treatment. Patients are being treated with antiretroviral drugs for many years and become older. The risk of developing side-effects due to long term antiretroviral therapy is therefore more and more likely. New alternative once-daily maintenance regimes are needed for those who are extensively pre-treated and experience side-effects or toxicity on standard treatment combinations. A possible once-daily, fully active maintenance regimen is the combination of atazanavir (unboosted), dolutegravir and lamivudine (PRADAII regimen). This combination is expected to be a safe, once-daily maintenance regimen with a favorable side-effect profile. The combination suits patients with intolerance and/or resistance to NRTIs, NNRTIs and ritonavir, who have a suppressed viral load. However, for this new combination the pharmacokinetic profile is unknown and there are no data on short-term and long-term safety and efficacy. This study wille therefore asses the pharmacokinetics, safety and efficacy in a small number of HIV-1 infected patients.