NCT00335192

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 and ABV will be compared in patients given these nucleosides with TDF and 30 days after the interruption of the TDF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
Last Updated

September 8, 2008

Status Verified

September 1, 2008

Enrollment Period

8 months

First QC Date

June 8, 2006

Last Update Submit

September 5, 2008

Conditions

HIV

Keywords

Intracellular concentrationsPlasma concentrationAbacavirTenofovirLamivudine (3TC)Pharmacokinetic interactions

Outcome Measures

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

    At baseline and week 4.

Secondary Outcomes (3)

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

    at baseline and week 4

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

    at baseline and week 4

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

    At week 4.

Study Arms (3)

1

EXPERIMENTAL

Phase I: 3TC + TDF + NVP or LPV/rtv Phase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: 3TC + LPV/rtv

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

2

EXPERIMENTAL

Phase I: ABV + TDF + NVP or LPV/rtv Phase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: ABV + LPV/rtv

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

3

EXPERIMENTAL

Phase I: 3TC + ABV + TDF + NVP or LPV/rtv Phase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: 3TC + ABV + LPV/rtv

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

Interventions

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

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

Also known as: Epivir, Kaletra
1
Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeksDRUG

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

Also known as: Ziagen, Kaletra
2
Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeksDRUG

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).

Also known as: Epivir, Ziagen, Kaletra
3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Interventions

TherapeuticsLamivudinelopinavir-ritonavir drug combinationVBA protocolabacavir

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Bonaventura Clotet, MD,PhD

    LLuita contra la Sida Foundation-HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 9, 2006

Study Start

January 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

September 8, 2008

Record last verified: 2008-09

Locations

ES(1)