NCT00356616TerminatedPhase 4
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
Germans Trias i Pujol Hospital1 site in 1 country24 target enrollmentStarted: September 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Variations in the immune status of patients in each group throughout follow-up.
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age>= 18 years.
- •HIV-1 infected patients.
- •Patients on antiretroviral treatment including NTRI + PI +/- NNRTI +/- fusion inhibitors at inclusion in the study.
- •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.
- •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.
- •CD4 lymphocytes >- 300 cells/mm3 in the last two determinations.
- •Subject able to follow the treatment period.
- •Acceptance of the study and signature of the informed consent form.
- •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/mm
- •Acute intercurrent disease or fever in the 15 days before inclusion.
Arms & Interventions
A
Experimental
Trizivir+ Tenofovir 2/day
Intervention: Trizivir (AZT+3HT+Abacavir) twice daily (Drug)
A
Experimental
Trizivir+ Tenofovir 2/day
Intervention: Viread (300 mg Tenofovir disoproxil fumarate) once daily (Drug)
Outcomes
Primary Outcomes
Variations in the immune status of patients in each group throughout follow-up.
Time Frame: 48 weeks
Secondary Outcomes
- 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 drop out of treatment.(weeks 12, 24, 36 and 48)
- Percentage of patients that increase viral load by > 100,000 copies/mL(weeks 12, 24, 36 and 48)
- Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.(weeks 12, 24, 36 and 48)
- Percentage of patients that increase viral load by > 0.5 log(weeks 12, 24, 36 and 48)
- Percentage of patients that drop out of the study due to intolerance or adverse effects.(weeks 12, 24, 36 and 48)
- Percentage of change in lipid determinations.(weeks 12, 24, 36 and 48 with regard to baseline)
- Percentage of patients that report changes, improvement or worsening in redistribution of body fat.(weeks 12, 24, 36 and 48)
- Percentage of patients that present adherence to the antiretroviral treatment > 95%.(weeks 12, 24, 36 and 48)
- Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires.(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)
Investigators
Study Sites (1)
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