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This study has been withdrawn prior to enrollment.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:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
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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 :
Lopinavir/ritonavir :
|
Drug: Lopinavir
Evaluation of second line antiretroviral regimen including boosted lopinavir
|
|
Experimental: Arm B : Atazanavir
Lamivudine/tenofovir :
Atazanavir/ritonavir :
|
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
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 June 17, 2013