HIV InfectionsPhase 3NCT00196612
Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
A Phase 3 study testing emtricitabine, FTC (drug), didanosine, ddI (drug) and efavirenz (drug) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- emtricitabine, FTC (drug), didanosine, ddI (drug) and efavirenz (drug)
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2001to Sep 2004
- 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
- HIV infected adults
- Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors
- CD4 cell count over 100/mm3
- HIV RNA below 400 copies/ml since 6 months
- Signed written informed consent
Who cannot join
- Previous treatment with non nucleoside analogue, ddI alone
- Pregnancy
- Alcool abuse
- Acute infection, past neurological or pancreatic disease, biological abnormalities
- Chemotherapy or immunotherapy
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Maladies Infectieuses, Hôpital Saint-Louis
Paris, 75475
About this study
Official title: Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.
Read the detailed description
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.
The trial is prolonged for a total of 48 weeks.
- Conditions
- HIV Infections
- Being tested
- emtricitabine, FTC (drug), didanosine, ddI (drug), efavirenz (drug)
- Keywords
- HIV Infections, Reverse Transcriptase Inhibitors, Treatment simplification
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emtricitabine, FTC (drug)Drug
didanosine, ddI (drug)Drug
efavirenz (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological success from W0 to W48
Secondary outcomes (7)
Progression of HIV infection
CD4 cell count
Safety
Treatment adherence
Quality of life
Viral mutations
Therapeutic strategy failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2001
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- 350 participants
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Triangle Pharmaceuticals, Gilead Sciences, Bristol-Myers Squibb, Dupont Applied Biosciences
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Molina, MD, PhD, Principal investigator, Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, FranceGenevieve Chene, MD, PhD, Study director, INSERM unité 593, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196612
- Sponsor's protocol ID
- ANRS 099 ALIZE
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2005
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gallien S, Journot V, Rozenbaum W, Yeni P, Morlat P, Poizot-Martin I, Reynes J, Reliquet V, Leclercq P, Simon F, Chene G, Molina JM; ALIZE (ANRS 099) Study Group. Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial). J Antimicrob Chemother. 2011 Jan;66(1):184-91. doi: 10.1093/jac/dkq395. Epub 2010 Oct 28.
PubMed 21036772Molina JM, Journot V, Morand-Joubert L, Yeni P, Rozenbaum W, Rancinan C, Fournier S, Morlat P, Palmer P, Dupont B, Goujard C, Dellamonica P, Collin F, Poizot-Martin I, Chene G; ALIZE (Agence Nationale de Recherches sur le SIDA 099) Study Team. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis. 2005 Mar 15;191(6):830-9. doi: 10.1086/428091. Epub 2005 Feb 10.
PubMed 15717256
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE
- ClinicalTrials.gov ID
- NCT00196612
- Acronym / sponsor ID
- ANRS 099 ALIZE
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Reverse Transcriptase Inhibitors, Treatment simplification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Triangle Pharmaceuticals, Gilead Sciences, Bristol-Myers Squibb, Dupont Applied Biosciences
- Study start
- Apr 2001
- Study completion
- Sep 2004
- First posted
- 20 Sep 2005 (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.
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.
Detailed description
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.
The trial is prolonged for a total of 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infected adults
- Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors
- CD4 cell count over 100/mm3
- HIV RNA below 400 copies/ml since 6 months
- Signed written informed consent
Key exclusion criteria (5 listed)
- Previous treatment with non nucleoside analogue, ddI alone
- Pregnancy
- Alcool abuse
- Acute infection, past neurological or pancreatic disease, biological abnormalities
- Chemotherapy or immunotherapy
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 |
|---|---|---|
| emtricitabine, FTC (drug) | Drug | – |
| didanosine, ddI (drug) | Drug | – |
| efavirenz (drug) | Drug | – |
Primary outcome
Virological success from W0 to W48
7 secondary outcomes
Progression of HIV infection
CD4 cell count
Safety
Treatment adherence
Quality of life
Viral mutations
Therapeutic strategy failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 21036772Gallien S, Journot V, Rozenbaum W, Yeni P, Morlat P, Poizot-Martin I, Reynes J, Reliquet V, Leclercq P, Simon F, Chene G, Molina JM; ALIZE (ANRS 099) Study Group. Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial). J Antimicrob Chemother. 2011 Jan;66(1):184-91. doi: 10.1093/jac/dkq395. Epub 2010 Oct 28.
- Results publication: PubMed 15717256Molina JM, Journot V, Morand-Joubert L, Yeni P, Rozenbaum W, Rancinan C, Fournier S, Morlat P, Palmer P, Dupont B, Goujard C, Dellamonica P, Collin F, Poizot-Martin I, Chene G; ALIZE (Agence Nationale de Recherches sur le SIDA 099) Study Team. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis. 2005 Mar 15;191(6):830-9. doi: 10.1086/428091. Epub 2005 Feb 10.
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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.
Jean-Michel Molina, MD, PhD principal investigator
Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France
Genevieve Chene, MD, PhD study director
INSERM unité 593, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing emtricitabine, FTC (drug), didanosine, ddI (drug) and efavirenz (drug) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 success from W0 to W48. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196612, which also lists 2 linked publications.
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 15 Jun 2026.