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HIV Infection clinical trials

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NCT ID: NCT02525146 Completed - HIV Infection Clinical Trials

Birmingham Access to Care Study

BA2C
Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a modified form of the ARTAS (Antiretroviral Treatment and Access to Services) intervention, adapted for HIV patients who have fallen out of care, can be successful in re-engaging patients in care and reducing HIV-1 viral load.

NCT ID: NCT02491242 Completed - HIV Infection Clinical Trials

Dolutegravir-based Dual Therapies in HIV-infected Patients With Virological Suppression

DOLBI
Start date: November 2015
Phase:
Study type: Observational [Patient Registry]

The objective of this study was to evaluate the efficacy and safety, and evolution of causes leading to change, of dual therapies based in Dolutegravir in patients requiring a change of virologically effective antiretroviral therapy.

NCT ID: NCT02489487 Completed - HIV-infection Clinical Trials

Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500

Start date: September 2014
Phase: Phase 1
Study type: Interventional

A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500 given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel design is used due to the long half life for VM-1500.

NCT ID: NCT02489435 Completed - HIV-infection Clinical Trials

Clinical Trial of Safety and Pharmacokinetics of VM-1500 After Multiple Oral Administration in Healthy Volunteers

Start date: July 2012
Phase: Phase 1
Study type: Interventional

The purpose of the study to assess safety and tolerability of VM-1500 and to determine main pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy subjects.

NCT ID: NCT02486133 Completed - HIV-Infection Clinical Trials

Dual Therapy With Boosted Darunavir + Dolutegravir

Dualis
Start date: July 2015
Phase: Phase 3
Study type: Interventional

A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV) Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with RTV-boosted DRV in combination with 2 NRTIs.

NCT ID: NCT02485509 Completed - HIV Infection Clinical Trials

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

Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT02473367 Completed - HIV Infection Clinical Trials

The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)

Start date: June 23, 2015
Phase: Phase 1
Study type: Interventional

In order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice daily as part of their HIV treatment regimen.

NCT ID: NCT02471430 Completed - HIV Infection Clinical Trials

Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy

ACTIVATE
Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a prospective, open-label, randomized, three-arm, dose-escalation exploratory pilot clinical trial involving HIV-1 infected participants treated with suppressive combination antiretroviral combination therapy (cART). The study will test whether combined treatment with the histone deacetylase inhibitor panobinostat and the immunomodulatory cytokine Interferon-alpha2a can reduce the residual reservoir of HIV-1 infected cells that persist during treatment with currently available antiretroviral drugs.

NCT ID: NCT02426840 Completed - HIV Infection Clinical Trials

Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among HIV-infected Children and Adolescents

CAL-D
Start date: April 2015
Phase: Phase 3
Study type: Interventional

Since there is no cure for HIV, therefore antiretroviral therapy must be taken life-long. Some of the HIV medications can negatively impact the health of the bone and is even more exacerbated in perinatally HIV-injected children and adolescents because this is the period when the bone peaks. Bone loss during this period can be devastating and increase the risk for developing weak bones later in life. Supplementation of calcium and vitamin D have not been well studied in HIV-infected children and adolescents in developing countries. Therefore it is not clear whether higher doses of these supplementations can thwart the damages or not.

NCT ID: NCT02426112 Completed - HIV Infection Clinical Trials

Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children

BREATHE
Start date: June 2016
Phase: Phase 3
Study type: Interventional

Chronic pulmonary disease (CLD) is the most common manifestation of HIV/AIDS among children, accounting for more than 50% of HIV-associated mortality. Recently, a novel form of CLD, affecting more than 30% of African HIV-infected older children was described by Ferrand et al in Zimbabwe, high-resolution CT scanning findings showed predominantly small airways disease consistent with constrictive obliterative bronchiolitis (OB). . Azithromycin has anti-inflammatory activity and treatment of CLD with this agent may lead to suppression of generalized immune activation. This specific aims of this project are to: 1. Primary objective: To investigate whether adjuvant treatment with azithromycin results in improvement in lung function in HIV-infected children with chronic lung disease, who are stable on antiretroviral therapy. 2. Secondary objectives: 1. To investigate the intervention effect on mortality, exacerbations of lung disease, quality of life, morbidity. 2. To investigate adverse events related to azithromycin treatment In total, 400 children aged 6-16 years, living with HIV and diagnosed with CLD will be enrolled at Harare Children´s Hospital in Harare (Zimbabwe) and Queen Elizabeth Central Hospital in Blantyre (Malawi). These will receive weekly treatment with azithromycin or placebo during 12 months. Another 100 children (50 per site) living with HIV but with no CLD will be enrolled as a comparison group for laboratory sub-studies. Lung function will be assess using spirometry and the Forced expiratory volume in the first minute (FEV1) will be the primary outcome. The mean change in FEV1 z-score levels will be compared between trial arms after 12 months of initiation of azithromycin treatment.