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Trial for the Optimal Timing of HIV Therapy After Cryptococcal Meningitis

2014-07-24 14:07:22 | BioPortfolio

Summary

To determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.

Description

After 7-10 days of amphotericin B therapy, subjects will be randomized in a 1:1 allocation to:

- Early initiation of ART (Experimental Group) = ART initiated within 72 hours after study entry, OR

- Standard initiation of ART (Control Group) = ART at >4 weeks after study entry

HIV therapy will be per national, in-country (Uganda) guidelines and at the discretion of the treating physician. Cryptococcal meningitis treatment will be using an amphotericin B based regimen per the national standard of care with additional safety monitoring.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cryptococcal Meningitis

Intervention

Early HIV Therapy Initiation, Standard HIV Therapy Initiation

Location

Mulago Naitonal Hospital
Kampala
Uganda

Status

Not yet recruiting

Source

University of Minnesota - Clinical and Translational Science Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:07:22-0400

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Medical and Biotech [MESH] Definitions

A eukaryotic initiation factor that binds to 40S ribosomal subunits. Although initially considered a "non-essential" factor for eukaryotic transcription initiation, eukaryotic initiation factor-1 is now thought to play an important role in localizing RIBOSOMES at the initiation codon of MRNA.

A component of eukaryotic initiation factor-4F that is involved in multiple protein interactions at the site of translation initiation. Thus it may serve a role in bringing together various initiation factors at the site of translation initiation.

A trimeric peptide initiation factor complex that associates with the 5' MRNA cap structure of RNA (RNA CAPS) and plays an essential role in MRNA TRANSLATION. It is composed of EUKARYOTIC INITIATION FACTOR-4A; EUKARYOTIC INITIATION FACTOR-4E; and EUKARYOTIC INITIATION FACTOR-4G.

A eukaryotic initiation factor that interacts with the 40S initiation complex and promotes the hydrolysis of the bound GTP. The hydrolysis of GTP causes the release of EUKARYOTIC INITIATION FACTOR-2 and EUKARYOTIC INITIATION FACTOR-3 from the 40S subunit and the subsequent joining of the 60S ribosomal subunit to the 40S complex to form the functional 80S initiation complex

A prokaryotic initiation factor that plays a role in recycling of ribosomal subunits for a new round of translational initiation. It binds to 16S RIBOSOMAL RNA and stimulates the dissociation of vacant 70S ribosomes. It may also be involved in the preferential binding of initiator tRNA to the 30S initiation complex.

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AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...


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