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:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00685191
First received: May 23, 2008
Last updated: November 6, 2009
Last verified: November 2009
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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 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
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
No publications provided
| Responsible Party: | 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 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Germans Trias i Pujol Hospital:
|
Raltegravir HIV dynamics viral load Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013