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

This study has been completed.
Sponsor:
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00685191
First received: May 23, 2008
Last updated: November 6, 2009
Last verified: November 2009

May 23, 2008
November 6, 2009
June 2008
April 2009   (final data collection date for primary outcome measure)
Change in viral load from day 0 to 7 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00685191 on ClinicalTrials.gov Archive Site
Intracellular levels of HIV-1 proviral DNA and LTR circles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Salvage antiretroviral therapy including raltegravir
Initiation of raltegravir-including salvage antiretroviral therapy
Other Name: RAL
Experimental: 1
HIV-1-infected subjects initiating raltegravir-including salvage therapy
Intervention: Drug: Salvage antiretroviral therapy including raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00685191
ITHACA
No
LLuita Sida Foundation
Germans Trias i Pujol Hospital
Not Provided
Principal Investigator: Bonaventura Clotet, MD,PhD Hospital U. Germans Trias i Pujol
Germans Trias i Pujol Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP