Status:
COMPLETED
Pilot Study to Compare the Pharmacokinetics Parameters in Plasma and Intracellular of Raltegravir Administered Once a Day in Adult Patients Infected With HIV
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare plasma and intracellular pharmacokinetic parameters of raltegravir 800 mg administered once daily in HIV infected patients.
Detailed Description
HIV integrase is the enzyme responsible for transferring the DNA encoded by HIV to host chromosomes, a necessary step for the replication of retroviruses. Raltegravir (RAL) is the first integrase inhi...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- HIV documented infection.
- Stable antiretroviral treatment for at least 4 weeks.
- HIV viral load in plasma \<50 copies / mL for at least 12 weeks
- Voluntary written informed consent.
Exclusion
- AIDS-defining illness in the previous 4 weeks
- Suspicion of inadequate adherence to antiretroviral therapy
- In the case of women, pregnant or breastfeeding, or non-use of contraceptives
- History or suspicion of failure to cooperate adequately
- Concomitant therapy in the two weeks prior to inclusion in the study with atazanavir, tenofovir, NNRTI, rifampicin, inhibitors of proton pump or other drugs with known interactions with raltegravir.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00995241
Start Date
November 1 2009
End Date
December 1 2009
Last Update
December 5 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025