HIVPhase 3ALISANCT01255371
A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir
A Phase 3 study testing Lopinavir and Atazanavir in people with HIV, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Lopinavir and Atazanavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- satisfactory compliance (>80%) to 1st line antiretroviral treatment
- signed informed consent
- agreement for contraception for women of childbearing age
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Tanzania1 site
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital
Mbeya
About this study
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
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.
- Conditions
- HIV
- Being tested
- Lopinavir, Atazanavir
- Keywords
- HIV, Second line antiretroviral treatment, Sub saharian Africa, Generic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LopinavirDrug
Evaluation of second line antiretroviral regimen including boosted lopinavir
AtazanavirDrug
Evaluation of second line antiretroviral regimen including boosted atazanavir
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Lopinavir | Active comparator | Emtricitabine/tenofovir :
* TDF300mg.FTC200mg (Fixed Dose Combination)
* 1 tablet per day
Lopinavir/ritonavir :
* LPV200mg/RTV50mg
* 2 tablets twice a day Receives: Drug: Lopinavir |
| Arm B : Atazanavir | Experimental | Lamivudine/tenofovir :
* 3TC300mg/TDF300mg (Fixed Dose Combination)
* 1 tablet per day
Atazanavir/ritonavir :
* ATV300mg/RTV100mg
* 2 tablets once a day Receives: Drug: Atazanavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological response
Proportion of patients with plasma HIV RNA < 50 copies/mL
Measured: 48 weeks
Secondary outcomes (7)
Virological response
Proportion of patients with plasma HIV RNA < 400 copies/mL
Measured: 12 and 24 weeks
Viral resistance
Incidence of resistance mutations after treatment failure (HIV RNA < 1000 copies/mL)
Measured: 12, 24 and 48 weeks
Clinical course of HIV infection
Mortality, occurence of clinical events stage 3 or 4 (WHO classification), immune reconstitution sundrome, non-AIDS clinical events including bacterial infections
Measured: Up to 48 weeks
Tolerance assessment
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.
Measured: 24 and 48 weeks
Adherence assessment
Measurement of pills consumption at each visit, face-to-face questionnaire with the pharmacist
Measured: At each protocol visit : week 2, 4, 12, 24, 36 and 48
Hepatitis B evaluation
Prevalence of HBs AG, HBe Ag, HBV viremia, and HBV asociated drug resistance mutations at baseline
Measured: At entry
Immunologic response
Variation of circulating total and CD4+ lymphocyte count between second line treatment initiation and 24 weeks/48 weeks
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startMar 2012
- Primary completionMay 2013 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: drug procurement issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- 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, Swiss National Science Foundation, University of Limpopo, NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania
- Responsible party
- Sponsor
- Investigators
- Eric Delaporte, Principal investigator, Institut de Recherche pour le DeveloppementIssakwisa Mwakyula, Principal investigator, NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, TanzaniaMzileni O Mogiyana, Principal investigator, University of LimpopoAlexandra Calmy, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255371
- Sponsor's protocol ID
- ANRS 12221 ALISA
- Other IDs
- IP.07.33011.004
- Acronym
- ALISA
- Status last verified
- Nov 2012
- First submitted
- 29 Nov 2010
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01255371
- Acronym / sponsor ID
- ALISA / ANRS 12221 ALISA
- Conditions
- HIV
- Keywords
- HIV, Second line antiretroviral treatment, Sub saharian Africa, Generic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: drug procurement issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- 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, Swiss National Science Foundation, University of Limpopo, NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania
- Study start
- Mar 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : Lopinavir | Active comparator | Drug: LopinavirEmtricitabine/tenofovir : * TDF300mg.FTC200mg (Fixed Dose Combination) * 1 tablet per day Lopinavir/ritonavir : * LPV200mg/RTV50mg * 2 tablets twice a day |
| Arm B : Atazanavir | Experimental | Drug: AtazanavirLamivudine/tenofovir : * 3TC300mg/TDF300mg (Fixed Dose Combination) * 1 tablet per day Atazanavir/ritonavir : * ATV300mg/RTV100mg * 2 tablets once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age 18 and above
- out patient
- documented HIV-1 infection
- first line treatment failure:
- satisfactory compliance (>80%) to 1st line antiretroviral treatment
Key exclusion criteria (9 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LopinavirEvaluation of second line antiretroviral regimen including boosted lopinavir | Drug | Arm A : Lopinavir |
| AtazanavirEvaluation of second line antiretroviral regimen including boosted atazanavir | Drug | Arm B : Atazanavir |
Primary outcome
Virological response
Time frame: 48 weeks
Proportion of patients with plasma HIV RNA < 50 copies/mL
7 secondary outcomes
Virological response
Time frame: 12 and 24 weeks
Viral resistance
Time frame: 12, 24 and 48 weeks
Clinical course of HIV infection
Time frame: Up to 48 weeks
Tolerance assessment
Time frame: 24 and 48 weeks
Adherence assessment
Time frame: At each protocol visit : week 2, 4, 12, 24, 36 and 48
Hepatitis B evaluation
Time frame: At entry
Immunologic response
Time frame: 24 and 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Delaporte principal investigator
Institut de Recherche pour le Developpement
Issakwisa Mwakyula principal investigator
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania
Mzileni O Mogiyana principal investigator
University of Limpopo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lopinavir and Atazanavir in people with HIV, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virological response (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2012.