Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

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

Summary

The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the influence of the individual characteristics on the pharmacokinetic parameters in the Spanish population of HIV-infected subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Amprenavir; Atazanavir Sulfate; Darunavir; Efavirenz; Fosamprenavir; HIV Protease Inhibitors; Indinavir; Lopinavir; Nelfinavir; Nevirapine; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir; Saquinavir; Tipranavir

Criteria

Inclusion Criteria:

1. Age higher than 18 years.

2. Documented HIV infection (at least one positive Western-blot)

3. Stable antiretroviral treatment with PI or NNRTI, no changes over the last 4 weeks.

4. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or negative pregnancy test.

Exclusion Criteria:

1. Subjects on treatment with more than one PI or with combinations of PI and NNRTI (the use of ritonavir in doses below 400 mg BID will not be regarded as a second PI).

2. Treatment with other drugs with known significant pharmacological interactions with the investigational drug over the previous two weeks.

3. Unsuitable adherence to treatment (one or more doses omitted in the last week, or two or more doses omitted in the last two weeks).

4. Presence of clinical findings or a background of gastrointestinal disease or digestive surgery that may interfere in the pharmacokinetics of the medication.

5. Active consumption of alcohol (>50 grams/day) or illegal drugs (except cannabis).

6. In the case of women, pregnancy or breastfeeding.

7. Record or suspicion of inability to cooperate properly