HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
Phase 4
Completed
- Conditions
- HIV Infections
- Interventions
- Drug: Salvage antiretroviral therapy including raltegravir
- Registration Number
- NCT00685191
- Lead Sponsor
- Germans Trias i Pujol Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Salvage antiretroviral therapy including raltegravir HIV-1-infected subjects initiating raltegravir-including salvage therapy
- Primary Outcome Measures
Name Time Method Change in viral load from day 0 to 7 1 week
- Secondary Outcome Measures
Name Time Method Intracellular levels of HIV-1 proviral DNA and LTR circles 24 weeks
Trial Locations
- Locations (1)
Hospital U. Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain