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This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. The patients population for this trial are treatment-experienced HIV-infected patients with CCR5-tropic virus and limited treatment options.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
PRO 140, Placebo, Optimized Background Regimen
Not yet recruiting
Published on BioPortfolio: 2015-06-29T07:12:21-0400
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of ant...
This study evaluates the efficacy, safety, and tolerability of UB-421 in conjunction with an existing failing antiretroviral therapy (ART) for 2 weeks and optimized background therapy (OBT...
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or l...
Study to Evaluate the Safety and Efficacy of GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
The primary objective of this study is to evaluate the antiviral activity of GS-6207 administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH...
This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.
Placebo treatments even if known to the patient to be placebo, so-called "open label placebo," may be effective in reducing chronic painThe effects of the extent of placebo education are poorly unders...
Evidence exists that placebo effects may influence hormone secretion. However, only few studies examined placebo effects in the endocrine system, including oxytocin placebo effects. We studied whether...
Tiotropium Respimat is an efficacious add-on to maintenance treatment in patients with symptomatic asthma. Currently, the Global Initiative for Asthma (GINA) strategy recommends tiotropium for patient...
Interest in the placebo effect of medicines has developed from the use of placebo treatments as controls in clinical trials into a whole new area of research around how placebos fit into a psychosocia...
One of the most important reasons for failure of placebo-controlled randomized controlled clinical trials (RCTs) is the lack of appropriate methodologies for detecting treatment effect (TE = differenc...
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A method of delineating blood vessels by subtracting a tissue background image from an image of tissue plus intravascular contrast material that attenuates the X-ray photons. The background image is determined from a digitized image taken a few moments before injection of the contrast material. The resulting angiogram is a high-contrast image of the vessel. This subtraction technique allows extraction of a high-intensity signal from the superimposed background information. The image is thus the result of the differential absorption of X-rays by different tissues.
Inbred strains of animals that are genetically identical except at a single locus, or a few specified loci, so that their known genetic differences are expressed in the same genetic background. A congenic strain is produced by outbreeding a strain and then eliminating the background by many generations of backcrosses while maintaining the desired genetic differences by selection of progeny. (Dorland, 28th ed)
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Voluntary cooperation of the patient in following a prescribed regimen.
Standard antiretroviral therapy (ART) consists of the combination of at least three antiretroviral (ARV) drugs to maximally suppress the HIV virus and stop the progression of HIV disease. Huge reductions have been seen in rates of death and suffering whe...