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A Study to Compare Two Anti-HIV Drug Combinations

2014-08-27 03:59:08 | BioPortfolio

Summary

The purpose of this study is to compare 2 anti-HIV drug combinations.

Description

Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Ritonavir, Efavirenz, Saquinavir

Location

Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham
Alabama
United States
35294

Status

Completed

Source

NIH AIDS Clinical Trials Information Service

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:08-0400

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Medical and Biotech [MESH] Definitions

Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.

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An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV.

Inhibitor or Reverse Transcriptases or of RNA-dIrected DNA polymerase.

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