Pilot Study to Compare the Pharmacokinetics Parameters in Plasma and Intracellular of Raltegravir Administered Once a Day in Adult Patients Infected With HIV

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborator: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

1. Age > 18 years.

2. HIV documented infection.

3. Stable antiretroviral treatment for at least 4 weeks.

4. HIV viral load in plasma <50 copies / mL for at least 12 weeks

5. Voluntary written informed consent.

Exclusion Criteria:

1. AIDS-defining illness in the previous 4 weeks

2. Suspicion of inadequate adherence to antiretroviral therapy

3. In the case of women, pregnant or breastfeeding, or non-use of contraceptives

4. History or suspicion of failure to cooperate adequately

5. 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.