NCT00386659

Brief Summary

Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2006

First QC Date

October 10, 2006

Last Update Submit

October 10, 2006

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.

Secondary Outcomes (3)

  • Degree and kinetics of recovery of the immune system.

  • New CDC C events

  • Mortality

Interventions

tenofovir + abacavir + lopinavir/ritonavirDRUG
tenofovir + abacavir + efavirenzDRUG

Eligibility Criteria

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

You may qualify if:

  • HIV-infection
  • Antiretroviral-naive
  • CD4 cell count below 100 cells/mm3

You may not qualify if:

  • Pregnancy
  • Current opportunistic infection requiring parenteral therapy
  • Current malignancies requiring parenteral chemotherapy
  • Any contraindication to the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital de Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

CSU Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirabacavirLopinavirRitonavirefavirenz

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 CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingThiazolesSulfur CompoundsAzoles

Study Officials

  • Josep M Gatell, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

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

October 10, 2006

First Posted

October 11, 2006

Last Updated

October 11, 2006

Record last verified: 2006-10

Locations

ES(4)