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

July 24, 2006
January 25, 2008
September 2005
June 2007   (final data collection date for primary outcome measure)
Variations in the immune status of patients in each group throughout follow-up. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
-Variations in the immune status of patients in each group throughout follow-up.
Complete list of historical versions of study NCT00356616 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of patients that increase viral load by > 0.5 log at weeks 12, 24, 36 and 48.
  • Percentage of patients that increase viral load by > 100,000 copies/mL at weeks 12, 24, 36 and 48.
  • Percentage of patients that present some clinical event, B or C classification according to the CDC, during the 48 weeks of follow-up.
  • Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification at weeks 12, 24, 36 and 48.
  • Percentage of patients that drop out of treatment at weeks 12, 24, 36 and 48.
  • Percentage of patients that drop out of the study due to intolerance or adverse effects at weeks 12, 24, 36 and 48.
  • Percentage of change in lipid determinations at weeks 12, 24, 36 and 48 with regard to baseline.
  • Percentage of patients that report changes, improvement or worsening in redistribution of body fat at weeks 12, 24, 36 and 48.
  • Percentage of patients that present adherence to the antiretroviral treatment > 95% at weeks 12, 24, 36 and 48.
  • Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires at weeks 12, 24, 36 and 48.
  • Percentage of patients that present an increase in the number of active drugs at the end of the study.
Not Provided
Not Provided
 
Immuno-Virological Efficacy of Combination With Trizivir +Tenofovir in Multiresistant HIV Patients
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
  • Experimental: A
    Trizivir+ Tenofovir 2/day
    Interventions:
    • Drug: Trizivir (AZT+3HT+Abacavir) twice daily
    • Drug: Viread (300 mg Tenofovir disoproxil fumarate) once daily
  • No Intervention: B
    antiretroviral treatment optimizated by genotyp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
June 2007
June 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00356616
TETRIZ, 2005-002203-17
No
Lluita Sida Foundation
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Principal Investigator: Bonaventura Clotet, MD,PhD LLuita contra la Sida Foundation-HIV Unit
Germans Trias i Pujol Hospital
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP