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

This study has been terminated.
(terminated)
Sponsor:
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00356616
First received: July 24, 2006
Last updated: January 25, 2008
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Trizivir (AZT+3HT+Abacavir) twice daily
Drug: Viread (300 mg Tenofovir disoproxil fumarate) once daily
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • Variations in the immune status of patients in each group throughout follow-up. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients that increase viral load by > 0.5 log [ Time Frame: weeks 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Percentage of patients that increase viral load by > 100,000 copies/mL [ Time Frame: weeks 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Percentage of patients that drop out of treatment. [ Time Frame: weeks 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
  • Percentage of patients that drop out of the study due to intolerance or adverse effects. [ Time Frame: weeks 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
  • Percentage of change in lipid determinations. [ Time Frame: weeks 12, 24, 36 and 48 with regard to baseline ] [ Designated as safety issue: Yes ]
  • Percentage of patients that report changes, improvement or worsening in redistribution of body fat. [ Time Frame: weeks 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Percentage of patients that present adherence to the antiretroviral treatment > 95%. [ Time Frame: weeks 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires. [ Time Frame: weeks 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Percentage of patients that present an increase in the number of active drugs. [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356616

Locations
Spain
H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
Principal Investigator: Bonaventura Clotet, MD,PhD LLuita contra la Sida Foundation-HIV Unit
  More Information

No publications provided

Responsible Party: Lluita Sida Foundation
ClinicalTrials.gov Identifier: NCT00356616     History of Changes
Other Study ID Numbers: TETRIZ, 2005-002203-17
Study First Received: July 24, 2006
Last Updated: January 25, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:
Antiretroviral treatment
virological failure
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 22, 2014