Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intracellular levels of HIV-1 proviral DNA and LTR circles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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.
  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 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

No publications provided

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
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases processed this record on February 25, 2015