Status:
COMPLETED
To Determine if There Are Pharmacokinetic Interactions at Plasma or Intracellular Level Between Nucleosides and Tenofovir
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
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 an...
Detailed Description
There is clear evidence of pharmacokinetic interaction between ddI+TDF. However, the interaction between TDF and other NRTIs, mainly at intracellular level, has not been so well studied. Since all th...
Eligibility Criteria
Inclusion
- HIV+ patients aged above 18 years.
- Undetectable HIV viral load in the last determination
- Patients capable of correct compliance according to clinical criteria.
- 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)
- 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.
- Ability to provide informed consent.
Exclusion
- Incorrect therapeutic compliance over the four weeks before the beginning of the study.
- Interruption or withdrawal from therapy during follow-up.
- Concomitant treatment with any drug which according to the clinician's criterion may interact with the investigational antiretrovirals, such as other antiretrovirals.
- Triple HAART therapy including Nevirapine (for phase II)
- Documented or suspected resistance to ABV, 3TC or lopinavir/rtv (for phase II).
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00335192
Start Date
January 1 2005
End Date
September 1 2005
Last Update
September 8 2008
Active Locations (1)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916