Back to resultsHIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Salvage antiretroviral therapy including raltegravir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Raltegravir, HIV, dynamics, viral load, Treatment Experienced
Eligibility 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.
Sites / Locations
- Hospital U. Germans Trias i Pujol
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
HIV-1-infected subjects initiating raltegravir-including salvage therapy
Outcomes
Primary Outcome Measures
Change in viral load from day 0 to 7
Secondary Outcome Measures
Intracellular levels of HIV-1 proviral DNA and LTR circles
Full Information
NCT ID
NCT00685191
First Posted
May 23, 2008
Last Updated
December 3, 2019
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
1. Study Identification
Unique Protocol Identification Number
NCT00685191
Brief Title
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
Official Title
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Raltegravir, HIV, dynamics, viral load, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
HIV-1-infected subjects initiating raltegravir-including salvage therapy
Intervention Type
Drug
Intervention Name(s)
Salvage antiretroviral therapy including raltegravir
Other Intervention Name(s)
RAL
Intervention Description
Initiation of raltegravir-including salvage antiretroviral therapy
Primary Outcome Measure Information:
Title
Change in viral load from day 0 to 7
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Intracellular levels of HIV-1 proviral DNA and LTR circles
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonaventura Clotet, MD,PhD
Organizational Affiliation
Hospital U. Germans Trias i Pujol
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital U. Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
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