NCT00532168

Brief Summary

There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

5.3 years

First QC Date

September 18, 2007

Last Update Submit

February 21, 2013

Conditions

HIV Infections

Keywords

advanced HIV-infected patientslate presentersantiretroviral therapyimmune reconstitutionTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned

    48 weeks

Study Arms (3)

1

EXPERIMENTAL

tenofovir plus emtricitabine plus efavirenz

Drug: tenofovir + emtricitabine + efavirenz

2

EXPERIMENTAL

tenofovir plus emtricitabine plus lopinavir-ritonavir

Drug: tenofovir + emtricitabine + lopinavir-ritonavir

3

EXPERIMENTAL

tenofovir plus emtricitabine plus atazanavir-ritonavir

Drug: tenofovir + emtricitabine + atazanavir-ritonavir

Interventions

tenofovir + emtricitabine + efavirenzDRUG

tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD

1
tenofovir + emtricitabine + lopinavir-ritonavirDRUG

tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose

2
tenofovir + emtricitabine + atazanavir-ritonavirDRUG

tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD

3

Eligibility Criteria

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

You may qualify if:

  • Chronic HIV-1 infection
  • Age 18 or more
  • Antiretroviral-naive
  • Baseline CD4+ count \<100 cels/mcL.
  • No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
  • Written informed consent

You may not qualify if:

  • Hypersensibility to study drugs.
  • Pregnancy or breastfeeding
  • Active OI requiring admission
  • Active lymphoma or malignancy (Kaposi sarcoma included)
  • Cl creatinine below 30 ml/min.
  • Liver failure
  • Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

  • Miro JM, Manzardo C, Ferrer E, Lonca M, Guardo AC, Podzamczer D, Domingo P, Curran A, Clotet B, Cruceta A, Lozano F, Perez I, Plana M, Gatell JM; Advanz-3 Study Group. Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial). J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):206-15. doi: 10.1097/QAI.0000000000000567.

    PMID: 25831464DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirEmtricitabineefavirenzLopinaviratazanavir, ritonavir drug combination

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 CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPyrimidinones

Study Officials

  • Jose M Miró, 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
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 20, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

ES(1)