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

Information source: Germans Trias i Pujol Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Trizivir (AZT+3HT+Abacavir) twice daily (Drug); Viread (300 mg Tenofovir disoproxil fumarate) once daily (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Germans Trias i Pujol Hospital

Official(s) and/or principal investigator(s):
Bonaventura Clotet, MD,PhD, Principal Investigator, Affiliation: LLuita contra la Sida Foundation-HIV Unit

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Variations in the immune status of patients in each group throughout follow-up.

Secondary outcome:

Percentage of patients that increase viral load by > 0.5 log

Percentage of patients that increase viral load by > 100,000 copies/mL

Percentage of patients that present some clinical event, B or C classification according to the CDC.

Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.

Percentage of patients that drop out of treatment.

Percentage of patients that drop out of the study due to intolerance or adverse effects.

Percentage of change in lipid determinations.

Percentage of patients that report changes, improvement or worsening in redistribution of body fat.

Percentage of patients that present adherence to the antiretroviral treatment > 95%.

Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires.

Percentage of patients that present an increase in the number of active drugs.

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

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

Starting date: September 2005
Last updated: January 25, 2008

Page last updated: August 23, 2015

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