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

This study has been completed.
Information provided by:
Germans Trias i Pujol Hospital Identifier:
First received: May 23, 2008
Last updated: November 6, 2009
Last verified: November 2009
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: 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.

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

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.
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Please refer to this study by its identifier: NCT00685191

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

Responsible Party: LLuita Sida Foundation Identifier: NCT00685191     History of Changes
Other Study ID Numbers: ITHACA
Study First Received: May 23, 2008
Last Updated: November 6, 2009

Keywords provided by Germans Trias i Pujol Hospital:
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 processed this record on May 24, 2017