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NCT ID: NCT01203332 Completed - HIV Clinical Trials

Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults

Start date: July 2010
Phase: N/A
Study type: Observational

The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. In 10 of the 13 sites, comparisons will be made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying undiagnosed HIV in our target group of adolescents and young adults. All study participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening. Participants with presumptive HIV positive screening results will be referred to the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical care. Linkage to care for ATN 096 study participants will be conducted in accordance with the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as part of this protocol are linked with treatment and care.

NCT ID: NCT01203293 Completed - Clinical trials for Generalized Anxiety Disorder

Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy (CBT) based interventions in general health settings that are delivered to reduce Generalized Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related quality of life.

NCT ID: NCT01200420 Completed - Hepatitis C Clinical Trials

Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C. Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.

NCT ID: NCT01199939 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients

INROADS
Start date: May 2010
Phase: Phase 2
Study type: Interventional

This study is a Phase II single arm, open-label, multicenter, study of 50 human immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.

NCT ID: NCT01196091 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.

NCT ID: NCT01195662 Completed - Type 2 Diabetes Clinical Trials

A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied

NCT ID: NCT01194414 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Start date: September 2010
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, parallel group study will compare the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive either RoActemra/Actemra 162 mg sc weekly plus iv placebo every 4 weeks, or RoActemra/Actemra 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period will be followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo will be administered in the open-label phase. Patients will continue on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment is 2 years.

NCT ID: NCT01193244 Completed - Prostate Cancer Clinical Trials

Study Comparing Orteronel Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

NCT ID: NCT01191268 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.

NCT ID: NCT01191255 Completed - Kidney Failure Clinical Trials

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.