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NCT ID: NCT01792752 Completed - HIV Clinical Trials

Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico

Proyecto PACTo
Start date: December 20, 2013
Phase: N/A
Study type: Interventional

The overall goal of this project is to implement and evaluate a community-level, structured approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico. The "Enhanced HIV Care Access and Retention Intervention" will: 1) identify drug users living with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2) provide direct HIV care services through a mobile health van; and 3) support identified HIV-infected drug users with patient navigators to enhance their ability to engage in HIV care and substance abuse treatment, to initiate antiretroviral therapy, and maintain adherence to their treatment regimens. The structural enhanced care approach will be evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The community-level success of the intervention will be assessed by evaluating virologic suppression (primary biological outcome), increased attendance to HIV care visits, uptake of antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn from each of the neighborhoods included in the intervention. The investigators will also evaluate the implementation process and cost of the enhanced care approach including implications for cost-effectiveness, feasibility of expansion, and sustainability.

NCT ID: NCT01792284 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus

IMAGINE 7
Start date: February 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of participation in this study is to compare the safety and efficacy of different dosing schedules of LY2605541 and how different dosing schedules of LY2605541 affect Hemoglobin A1c (HbA1c). Participants will be treated for up to 36 weeks with LY2605541 (one 12-week Lead-in period and two 12-week Randomization periods) and will participate in a total of 42 weeks of total study enrollment, including a 2-week Screening period and a 4-week Follow-up period.

NCT ID: NCT01790438 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes

IMAGINE 6
Start date: March 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: - Change in participants' overall blood sugar control - The rate of night time low blood sugar episodes - The number of participants that reach blood sugar targets without low night time blood sugar episodes - The total number of low blood sugar episodes reported

NCT ID: NCT01780831 Completed - HIV Infections Clinical Trials

Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection

Start date: January 28, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety and pharmacokinetics (PK) of raltegravir (RAL) when given to HIV-1-exposed, normal birth weight newborn infants at risk of acquiring HIV-1 infection. (PK is the study of the time course of absorption, distribution, metabolism, and excretion of drugs in the body.) The primary goal of this study was to determine a dose of RAL that was safe and met the PK targets for infants when administered during the first 6 weeks of life in addition to standard of care antiretroviral (ARV) agents for prevention of perinatal transmission.

NCT ID: NCT01780506 Completed - HIV Infections Clinical Trials

Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

Start date: December 26, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

NCT ID: NCT01777191 Completed - Plaque Psoriasis Clinical Trials

Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis

UNCOVER-A
Start date: March 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.

NCT ID: NCT01774968 Completed - Clinical trials for Diabetes Mellitus, Type 2

Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes

Start date: February 2013
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.

NCT ID: NCT01767194 Completed - Clinical trials for Recurrent Neuroblastoma

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

Start date: February 12, 2013
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.

NCT ID: NCT01756339 Completed - Clinical trials for Community-acquired Bacterial Pneumonia

Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

SOLITAIRE-ORAL
Start date: December 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

NCT ID: NCT01752855 Completed - Clinical trials for Rheumatoid Arthritis

Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

Start date: December 2012
Phase: Phase 2
Study type: Interventional

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.