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Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl (ADVANZ-3)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
tenofovir + emtricitabine + efavirenz
tenofovir + emtricitabine + lopinavir-ritonavir
tenofovir + emtricitabine + atazanavir-ritonavir
Sponsored by
Juan A. Arnaiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring advanced HIV-infected patients, late presenters, antiretroviral therapy, immune reconstitution, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

tenofovir plus emtricitabine plus efavirenz

tenofovir plus emtricitabine plus lopinavir-ritonavir

tenofovir plus emtricitabine plus atazanavir-ritonavir

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 18, 2007
Last Updated
February 21, 2013
Sponsor
Juan A. Arnaiz
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1. Study Identification

Unique Protocol Identification Number
NCT00532168
Brief Title
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
Acronym
ADVANZ-3
Official Title
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
advanced HIV-infected patients, late presenters, antiretroviral therapy, immune reconstitution, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
tenofovir plus emtricitabine plus efavirenz
Arm Title
2
Arm Type
Experimental
Arm Description
tenofovir plus emtricitabine plus lopinavir-ritonavir
Arm Title
3
Arm Type
Experimental
Arm Description
tenofovir plus emtricitabine plus atazanavir-ritonavir
Intervention Type
Drug
Intervention Name(s)
tenofovir + emtricitabine + efavirenz
Intervention Description
tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
Intervention Type
Drug
Intervention Name(s)
tenofovir + emtricitabine + lopinavir-ritonavir
Intervention Description
tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
Intervention Type
Drug
Intervention Name(s)
tenofovir + emtricitabine + atazanavir-ritonavir
Intervention Description
tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD
Primary Outcome Measure Information:
Title
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Miró, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25831464
Citation
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.
Results Reference
derived

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Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl

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