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Completed

NCT Number: NCT00335192

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

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.

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Key information

Conditions

HIV

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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 the NRTIs are anabolized at intracellular level by numerous kinases, and are transported by passive carrier systems, the interaction may be between TDF and other NRTIs.

This study aims to investigate the pharmacokinetic interactions between the TDF and the nucleosides abacavir (ABV) and lamivudine (3TC) at plasma and intracellular level.

With this objective, intracellular and plasma levels will be analysed in a group of patients that receive the combinations 3TC +TDF, ABV+TDF and 3TC+ABV+TDF together with lopinavir/rtv or nevirapine. Subsequently, in a second phase of the study, in the group of patients given ABV and/or 3TC + TDF + lopinavir/rtv, the pharmacokinetic determinations will be repeated after a 4-week interruption of the TDF .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).

Treatment and study plan

Patients in treatment with 3TC + TDF + LPV/rtv, stop tenofovir during 4 weeks

Drug

3TC (300 mg/24 h, 1 tablet/24 h) + Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)

Other names: Epivir, Kaletra

Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeks

Drug

ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)

Other names: Ziagen, Kaletra

Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeks

Drug

3TC (300 mg/24 h, 1 tablet/24 h)+ ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h).

Other names: Epivir, Ziagen, Kaletra

Primary outcomes

  1. The primary endpoint will be the variation between the intracellular levels of 3TC and ABC before and after the interruption of the treatment with TDF

    Time frame: At baseline and week 4.

Secondary outcomes

  1. Variations between the plasma levels of 3TC and ABC before and after interruption of the treatment with TDF.

    Time frame: at baseline and week 4

  2. Correlation between the intracellular and plasma levels of 3TC, ABC and TDF.

    Time frame: at baseline and week 4

  3. Changes in the intracellular levels of TDF following the withdrawal of the drug.

    Time frame: At week 4.

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Registry information

Official study title

Determination of Plasma and Intracellular Levels of Nucleoside Reverse Transcriptase Inhibitors (NRTI) and of Nucleotide Analog Tenofovir Disoproxil Fumarate (TDF) in Patients Treated With Abacavir and/or Lamivudine Given With or Without TDF.

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jun 9, 2006
Registry last updated
Sep 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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