HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

Germans Trias i Pujol Hospital15 enrolled

Overview

The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Salvage antiretroviral therapy including raltegravirDRUG

Initiation of raltegravir-including salvage antiretroviral therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance. * Subjects initiating raltegravir plus another fully active antiretroviral drug. Exclusion Criteria: * Pregnancy, or fertile women willing to be pregnant. * Active substance abuse or major psychiatric disease.

Locations (1)

Hospital U. Germans Trias i Pujol

Badalona, Barcelona, Spain

Outcomes

Primary Outcomes

Change in viral load from day 0 to 7

Time frame: 1 week

Secondary Outcomes

Intracellular levels of HIV-1 proviral DNA and LTR circles

Time frame: 24 weeks

Data from ClinicalTrials.gov

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