HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
Germans Trias i Pujol Hospital
Information provided by (Responsible Party)
Germans Trias i Pujol Hospital
First received: May 23, 2008
Last updated: November 6, 2009
Last Verified: November 2009
History of Changes
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.
Drug : Salvage antiretroviral therapy including raltegravir
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 ]
- Intracellular levels of HIV-1 proviral DNA and LTR circles [ Time Frame: 24 weeks ]
|Study Start Date:||June 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
HIV-1-infected subjects initiating raltegravir-including salvage therapy
Salvage antiretroviral therapy including raltegravir
Initiation of raltegravir-including salvage antiretroviral therapy
Other Name: RAL
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
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Pregnancy, or fertile women willing to be pregnant.
- Active substance abuse or major psychiatric disease.
Contacts and LocationsChoosing 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 Show More
|Hospital U. Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
Sponsors and CollaboratorsGermans Trias i Pujol Hospital
|Principal Investigator:||Bonaventura Clotet, MD,PhD||Hospital U. Germans Trias i Pujol|
|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
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.