Immuno-Virological Efficacy of Combination With Trizivir +Tenofovir in Multiresistant HIV Patients

January 25, 2008 updated by: Germans Trias i Pujol Hospital

Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure

To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study has been designed to determine whether the use of a regimen based exclusively on NTRI, containing tenofovir, zidovudine and lamivudine, is able to preserve immunological status in patients with detectable viral load for whom an efficacious salvage regimen cannot be designed, slowing the progression of the viral load and reducing antiretroviral treatment-associated toxicity. In order to complete the salvage regimen without increasing the number of tablets too much, Trizivir plus tenofovir as investigational treatment will be used.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • H.U. Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age>= 18 years.
  2. HIV-1 infected patients.
  3. Patients on antiretroviral treatment including NTRI + PI +/- NNRTI +/- fusion inhibitors at inclusion in the study.
  4. Virological failure, defined as 2 determinations with viral load >1,000 copies/mL in the last 6 months, during stable HAART therapy over the previous 6 months.

  5. Genotype or phenotype resistance to three families of antiretrovirals (PI, NTRI and NNRTI) demonstrated in genotype study carried out in the last 48 weeks and defined as:

    • 3 or more TAMS of the following: M41L, E44D, D67N, V118I, L210W, T215Y/F, K219Q/E.
    • Existence of the M184V mutation or probable presence in the cellular archives.
    • 5 or more mutations that confer resistance to PI of the following: I10F/I/R/V, V32I, M46I/L, I54V/M/L, V82A/F/T/S/V, I84V/A/C, L90M.
    • Existence of 1 or more mutations that confer resistance to NNRTI, or probable presence in the cellular archives of: K103N, Y181C/I/Y, G190S/A/G.
  6. CD4 lymphocytes >- 300 cells/mm3 in the last two determinations.
  7. Subject able to follow the treatment period.
  8. Acceptance of the study and signature of the informed consent form.
  9. 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.

Exclusion Criteria:

  • Suspicion of previous incorrect adherence.
  • Pregnancy or breastfeeding
  • Suspicion of intolerance to any investigational drug.
  • Record of any disease which, according to clinical criteria, may reoccur with the proposed change of therapy (sarcoma, lymphoma, etc).
  • CD4 Nadir below 200 cel/mm3.
  • Acute intercurrent disease or fever in the 15 days before inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Trizivir+ Tenofovir 2/day
Drug: Trizivir (AZT+3HT+Abacavir) twice daily
Trizivir (AZT+3HT+Abacavir) twice daily
Drug: Viread (300 mg Tenofovir disoproxil fumarate) once daily
Viread (300 mg Tenofovir disoproxil fumarate) once daily
No Intervention: B
antiretroviral treatment optimizated by genotyp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variations in the immune status of patients in each group throughout follow-up.
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients that increase viral load by > 0.5 log
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of patients that increase viral load by > 100,000 copies/mL
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of patients that present some clinical event, B or C classification according to the CDC.
Time Frame: during the 48 weeks of follow-up
during the 48 weeks of follow-up
Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of patients that drop out of treatment.
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of patients that drop out of the study due to intolerance or adverse effects.
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of change in lipid determinations.
Time Frame: weeks 12, 24, 36 and 48 with regard to baseline
weeks 12, 24, 36 and 48 with regard to baseline
Percentage of patients that report changes, improvement or worsening in redistribution of body fat.
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of patients that present adherence to the antiretroviral treatment > 95%.
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires.
Time Frame: weeks 12, 24, 36 and 48
weeks 12, 24, 36 and 48
Percentage of patients that present an increase in the number of active drugs.
Time Frame: at the end of the study
at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 25, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TETRIZ
  • 2005-002203-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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