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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Germans Trias i Pujol Hospital


Information provided by (Responsible Party)
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier
NCT00685191

First received: May 23, 2008
Last updated: November 6, 2009
Last Verified: November 2009
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


Responsible Party: LLuita Sida Foundation, LLuita Sida Foundation  
ClinicalTrials.gov 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:

Raltegravir
HIV
dynamics
viral load
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Raltegravir Potassium

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.