Status:
TERMINATED
Immuno-Virological Efficacy of Combination With Trizivir +Tenofovir in Multiresistant HIV Patients
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00356616
Start Date
September 1 2005
End Date
June 1 2007
Last Update
January 29 2008
Active Locations (1)
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1
H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916