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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

HIV-1-infected subjects initiating raltegravir-including salvage therapy

Group Type EXPERIMENTAL

Salvage antiretroviral therapy including raltegravir

Intervention Type DRUG

Initiation of raltegravir-including salvage antiretroviral therapy

Interventions

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Salvage antiretroviral therapy including raltegravir

Initiation of raltegravir-including salvage antiretroviral therapy

Intervention Type DRUG

Other Intervention Names

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RAL

Eligibility Criteria

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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.