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NCT ID: NCT01944371 Completed - HIV Clinical Trials

Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study

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

The purpose of this study is to determine the safety, pharmacology and bioactivity of disulfiram in antiretroviral treated HIV-infected adults. The investigators primary hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in CD4+ T-cells in patients on suppressive antiretroviral therapy (ART).

NCT ID: NCT01943851 Completed - Neoplasms Clinical Trials

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies

Start date: May 14, 2014
Phase: Phase 2
Study type: Interventional

This is an open-label repeat dose, multicenter, 2-part study to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily (QD) orally. Part 1 of the study is a dose escalation phase to select the recommended Part 2 dose (RP2D) based on the safety, PK, and PD profiles observed after oral administration of GSK525762. Eligible subjects with select relapsed refractory hematological malignancies (acute myeloid leukemia [AML], non-Hodgkin's Lymphoma [NHL]and multiple myeloma [MM]), will be enrolled in the QD and/or BID dosing cohorts until a MTD is established. Subjects may continue treatment in the study until disease progression, unacceptable toxicity, or withdrawal of consent. . Upon determination of the MTD, twice daily (BID) dosing cohorts may be opened to collect additional safety data and evaluate the preliminary efficacy of GSK525762 administered BID. Part 2 will explore clinical activity at the MTD or RP2D; separate expansion cohorts will be planned for acute myeloid leukemia (AML), non-Hodgkin's Lymphoma (NHL, including an exploratory sub-cohort of subjects with myc and B-Cell Leukemia (BCL)2 and/or BCL6 rearrangements/overexpression [double- and triple-hit lymphoma]), and multiple myeloma (MM). This is the first study of this agent to be conducted in subjects with these relapsed and/or refractory hematological malignancies for which no standard therapies are anticipated to result in a durable remission.

NCT ID: NCT01943045 Completed - Diabetes Mellitus Clinical Trials

Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.

NCT ID: NCT01942135 Completed - Clinical trials for Metastatic Breast Cancer

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Start date: September 26, 2013
Phase: Phase 3
Study type: Interventional

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

NCT ID: NCT01941693 Completed - Depression Clinical Trials

A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity

Start date: March 2007
Phase: N/A
Study type: Interventional

There is a high rate of psychological comorbidity in people suffering from alcohol dependence. There is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety or depression. This study will test the efficacy of a novel integrated intervention for comorbid alcohol dependence and anxiety or mood disorder.

NCT ID: NCT01940900 Terminated - Clinical trials for Age-Related Macular Degeneration

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

NCT ID: NCT01940887 Terminated - Clinical trials for Age-Related Macular Degeneration

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

NCT ID: NCT01940471 Completed - Clinical trials for HBeAg-positive Chronic Hepatitis B

Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen

Start date: September 11, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

NCT ID: NCT01940341 Completed - Clinical trials for HBeAg-negative Chronic Hepatitis B

Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen

Start date: September 12, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

NCT ID: NCT01940198 Completed - HIV Clinical Trials

Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia

REfLecT
Start date: April 2010
Phase: N/A
Study type: Observational

This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.