NCT00356616

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 29, 2008

Status Verified

November 1, 2007

Enrollment Period

1.7 years

First QC Date

July 24, 2006

Last Update Submit

January 25, 2008

Conditions

HIV Infections

Keywords

Antiretroviral treatmentvirological failureHIV

Outcome Measures

Primary Outcomes (1)

  • Variations in the immune status of patients in each group throughout follow-up.

    48 weeks

Secondary Outcomes (11)

  • Percentage of patients that increase viral load by > 0.5 log

    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 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.

    weeks 12, 24, 36 and 48

  • Percentage of patients that drop out of treatment.

    weeks 12, 24, 36 and 48

  • +6 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Trizivir+ Tenofovir 2/day

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

B

NO INTERVENTION

antiretroviral treatment optimizated by genotyp

Interventions

Trizivir (AZT+3HT+Abacavir) twice dailyDRUG

Trizivir (AZT+3HT+Abacavir) twice daily

A
Viread (300 mg Tenofovir disoproxil fumarate) once dailyDRUG

Viread (300 mg Tenofovir disoproxil fumarate) once daily

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>= 18 years.
  • HIV-1 infected patients.
  • 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:
  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H.U. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir, lamivudine, and zidovudine drug combinationTenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bonaventura Clotet, MD,PhD

    LLuita contra la Sida Foundation-HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 26, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

January 29, 2008

Record last verified: 2007-11

Locations

ES(1)