To Determine if There Are Pharmacokinetic Interactions at Plasma or Intracellular Level Between Nucleosides and Tenofovir

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if there are pharmacokinetic interactions between the NRTI 3TC and ABV, and the TDF nucleotide. For this purpose, the intracellular and plasma levels of 3TC and ABV will be compared in patients given these nucleosides with TDF and 30 days after the interruption of the TDF.

• Phase: Phase 4
• 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: Abacavir; Lamivudine; Lopinavir; Reverse Transcriptase Inhibitors; Tenofovir

Criteria

Inclusion Criteria:

1. HIV+ patients aged above 18 years.

2. Undetectable HIV viral load in the last determination

3. Patients capable of correct compliance according to clinical criteria.

4. Patients on triple HAART therapy for the previous 3 months including 3TC and/or ABV and TDF, with a PI (Lopinavir/ritonavir) or an NNRTI (Nevirapine)

5. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.

6. Ability to provide informed consent.

Exclusion Criteria:

1. Incorrect therapeutic compliance over the four weeks before the beginning of the study.

2. Interruption or withdrawal from therapy during follow-up.

3. Concomitant treatment with any drug which according to the clinician's criterion may interact with the investigational antiretrovirals, such as other antiretrovirals.

4. Triple HAART therapy including Nevirapine (for phase II)

5. Documented or suspected resistance to ABV, 3TC or lopinavir/rtv (for phase II).