Trial record 19 of 31 for:    " November 01, 2010":" December 01, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir (ALISA)

This study has been withdrawn prior to enrollment.
(drug procurement issues)
Sponsor:
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Ludwig-Maximilians - University of Munich
Institute of Tropical Medicine, Belgium
Institut de Recherche pour le Developpement, France
Swiss National Science Foundation
University of Limpopo
NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01255371
First received: November 29, 2010
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen.

This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.


Condition Intervention Phase
HIV
Drug: Lopinavir
Drug: Atazanavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase III Trial of Second-line Antiretroviral Treatment Strategies in African Adults (Tanzania Ans South Africa) Using Atazanavir or Lopinavir/Ritonavir

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Virological response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients with plasma HIV RNA < 50 copies/mL


Secondary Outcome Measures:
  • Virological response [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    Proportion of patients with plasma HIV RNA < 400 copies/mL

  • Viral resistance [ Time Frame: 12, 24 and 48 weeks ] [ Designated as safety issue: No ]
    Incidence of resistance mutations after treatment failure (HIV RNA < 1000 copies/mL)

  • Clinical course of HIV infection [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
    Mortality, occurence of clinical events stage 3 or 4 (WHO classification), immune reconstitution sundrome, non-AIDS clinical events including bacterial infections

  • Tolerance assessment [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
    Proportion of adverse events related to antiretroviral treatment, proportion of treatement discontinuations due to antiretroviral side effect, variation of biological parameters and metabolic markers between second line antiretroviral initiation and 24/48 weeks.

  • Adherence assessment [ Time Frame: At each protocol visit : week 2, 4, 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
    Measurement of pills consumption at each visit, face-to-face questionnaire with the pharmacist

  • Hepatitis B evaluation [ Time Frame: At entry ] [ Designated as safety issue: No ]
    Prevalence of HBs AG, HBe Ag, HBV viremia, and HBV asociated drug resistance mutations at baseline

  • Immunologic response [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
    Variation of circulating total and CD4+ lymphocyte count between second line treatment initiation and 24 weeks/48 weeks


Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A : Lopinavir

Emtricitabine/tenofovir :

  • TDF300mg.FTC200mg (Fixed Dose Combination)
  • 1 tablet per day

Lopinavir/ritonavir :

  • LPV200mg/RTV50mg
  • 2 tablets twice a day
Drug: Lopinavir
Evaluation of second line antiretroviral regimen including boosted lopinavir
Experimental: Arm B : Atazanavir

Lamivudine/tenofovir :

  • 3TC300mg/TDF300mg (Fixed Dose Combination)
  • 1 tablet per day

Atazanavir/ritonavir :

  • ATV300mg/RTV100mg
  • 2 tablets once a day
Drug: Atazanavir
Evaluation of second line antiretroviral regimen including boosted atazanavir

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 and above
  • out patient
  • documented HIV-1 infection
  • first line treatment failure:

    • after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors
    • two measurements of plasma HIV RNA levels > 1000 copies/mL after at least 6 months of uninterrupted treatment or without any major modification
  • satisfactory compliance (>80%) to 1st line antiretroviral treatment
  • signed informed consent
  • agreement for contraception for women of childbearing age

Exclusion Criteria:

  • HIV-2 infection or HIV-1/HIV-2 coinfection
  • uncontrolled, ongoing opportunistic infection or of any severe or progressive disease including active TB
  • first line antiretroviral treatment with a protease inhibitor or tenofovir
  • ongoing treatment with rifampicin
  • severe hepatic insufficiency (PT < 50%)
  • ALT < 3 times the upper limit of normal
  • creatinine clearance calculated by Cockcroft's formula < 50 mL/min
  • Hb <=8 g/dL; platelets < 50,000 cells/mm3; neutrophils < 500 cells/mm3
  • pregnancy and lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255371

Locations
South Africa
Tshepang clinic, Limpopo University
Pretoria, South Africa
Tanzania
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital
Mbeya, Tanzania
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
European and Developing Countries Clinical Trials Partnership (EDCTP)
Ludwig-Maximilians - University of Munich
Institute of Tropical Medicine, Belgium
Institut de Recherche pour le Developpement, France
Swiss National Science Foundation
University of Limpopo
NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania
Investigators
Principal Investigator: Eric Delaporte Institut de Recherche pour le Developpement, France
Principal Investigator: Issakwisa Mwakyula NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania
Principal Investigator: Mzileni O Mogiyana University of Limpopo
Principal Investigator: Alexandra Calmy University of Geneva, Switzerland
  More Information

No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01255371     History of Changes
Other Study ID Numbers: ANRS 12221 ALISA, IP.07.33011.004
Study First Received: November 29, 2010
Last Updated: November 7, 2012
Health Authority: Tanzania: Ministry of Health
South Africa: Medicines Control Council

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV
Second line antiretroviral treatment
Sub saharian Africa
Generic

Additional relevant MeSH terms:
Ritonavir
Lopinavir
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014