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

ANRS, Emerging Infectious Diseases

Status and phase: Withdrawn; Phase 3

Conditions: HIV

Treatments: Drug: Atazanavir; Drug: Lopinavir

Study type: Interventional

Funder types: Other

Identifiers

NCT01255371

ANRS 12221 ALISA

IP.07.33011.004 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm A : Lopinavir

Active Comparator group

Description:

Emtricitabine/tenofovir : * TDF300mg.FTC200mg (Fixed Dose Combination) * 1 tablet per day Lopinavir/ritonavir : * LPV200mg/RTV50mg * 2 tablets twice a day

Treatment:

Drug: Lopinavir

Arm B : Atazanavir

Experimental group

Description:

Lamivudine/tenofovir : * 3TC300mg/TDF300mg (Fixed Dose Combination) * 1 tablet per day Atazanavir/ritonavir : * ATV300mg/RTV100mg * 2 tablets once a day

Treatment:

Drug: Atazanavir