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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685191
First Posted: May 28, 2008
Last Update Posted: November 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Germans Trias i Pujol Hospital
  Purpose
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.

Condition Intervention Phase
HIV Infections Drug: Salvage antiretroviral therapy including raltegravir Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • Change in viral load from day 0 to 7 [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Intracellular levels of HIV-1 proviral DNA and LTR circles [ Time Frame: 24 weeks ]

Enrollment: 15
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HIV-1-infected subjects initiating raltegravir-including salvage therapy
Drug: Salvage antiretroviral therapy including raltegravir
Initiation of raltegravir-including salvage antiretroviral therapy
Other Name: RAL

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685191


Locations
Spain
Hospital U. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
Principal Investigator: Bonaventura Clotet, MD,PhD Hospital U. Germans Trias i Pujol
  More Information

Responsible Party: LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00685191     History of Changes
Other Study ID Numbers: ITHACA
First Submitted: May 23, 2008
First Posted: May 28, 2008
Last Update Posted: November 9, 2009
Last Verified: November 2009

Keywords provided by Germans Trias i Pujol Hospital:
Raltegravir
HIV
dynamics
viral load
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action