HIV-1-infectionPhase 3MODERATONCT04022967
ANRS 12372 MODERATO Study
A Phase 3 study testing dolutegravir, atazanavir boosted with ritonavir and tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 5 sites in 3 countries.
Trial summary
MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso). HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- dolutegravir, atazanavir boosted with ritonavir and tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Nov 2020to 30 Dec 2024
- 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-1 infection
- Age of legal majority
- CD4 > 200 cells/mm3 at pre-inclusion
- Start first-line ART with non-nucleotide reverse transcriptase inhibitors including TDF+XTC+EFV for at least two years without a past history of virological failure, OR
- Be on TDF+XTC+EFV for at least two years then DTG+XTC+TDF without a past history of virological failure, OR
- Be on DTG+XTC+TDF (1st line regimen) for at least two years without a past history of virological failure
Show all 10Show fewer
- Absence of past history of virological failure (viral load above the threshold corresponding to the test used); two blips between 50 and 200 copies/ml are allowed.
- At least 2 consecutive HIV-1 RNA < 50 copies/ml within past 2 years, including HIV-1 RNA at pre-inclusion
- Women with pregnancy potential are required to use an effective contraceptive method throughout the study follow up.
- Signed informed consent
Who cannot join
- HIV-2 infection or HIV-1+2 infection
- CD4 nadir <100 cells/mm3
- Chronic Hepatitis B (HBs Ag positive in the pre-inclusion balance)
- Ongoing active Tuberculosis
- Ongoing severe opportunistic infection
- Ongoing chemotherapy or immunotherapy
Show all 14Show fewer
- Grade > 2 hemoglobin, neutrophil or platelet disorder
- ALT≥ 3 times the upper limit of normal value
- Creatinine clearance < 50 ml/min (CKD-EPI)
- Allergy to a trial drugs or drug component
- Ongoing pregnancy or Refusal of contraception
- Patient at risk of non-compliance
- Ongoing treatment with a drug that should not be associated with one of the drugs used in the study (cf appendix E page 77)
- Any symptoms or biological findings suggestive of a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions that may interfere with the interpretation of test results or jeopardize the health of patients
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Burkina Faso2 sites
Hôpital de jour, Service des maladies infectieuses, CHU Sourô Sanou
Bobo-Dioulasso
Service de médecine interne, CHU Yalgado Ouédraogo
Ouagadougou
Côte d’Ivoire2 sites
Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
Abidjan
Service des Maladies Infectieuses et Tropicales (SMIT), CHU de Treichville
Abidjan
Cameroon1 site
Service des Maladies Infectieuses, Hôpital du jour, Hôpital Central
Yaoundé
About this study
Official title: Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz (TDF+3TC+EFV) or Dolutegravir + Lamivudine + Tenofovir (DTG+3TC+TDF) in West and Central African HIV-1 Infected Patients
MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso).
HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks.
The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks
Read the detailed description
In HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed (viral load < detection limit of the technique used) for at least two years: to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+ 3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks, in Cameroon, Côte d'Ivoire and Burkina Faso.
This is a trial including two strategies (dual maintenance therapy and triple reference therapy) and three ART regimens (DTG+3TC and ATV/r+3TC used in the maintenance strategy and TDF+3TC+EFV/ DTG+3TC+TDF used in the reference strategy).
The primary analysis will compare the two strategies. Secondary analyses will compare the three ART regimens two by two.
In order to make these secondary analyses possible, participants will be randomly assigned, at inclusion, to each of the three ART regimens (arm 1: DTG+3TC; arm 2: ATV/r+3TC; arm 3: TDF+3TC+EFV / DTG+3TC+TDF). The maintenance strategy will include arm 1 and 2. The reference strategy will include arm 3
Number of participants : 480 (160 in each ART regimen, ie 320 in the dual maintenance therapy strategy and 160 in the triple therapy reference strategy)
The primary endpoint is treatment success, as defined by using the FDA snapshot algorithm : patients who are still continuing the assigned strategy and whose last available plasma HIV-1 RNA in the the window analysis (90 to 102 weeks) is <50 copies/ml at the end of the window analysis (90 to 102 weeks)
- Conditions
- HIV-1-infection
- Being tested
- dolutegravir, atazanavir boosted with ritonavir, tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir, Lamivudine
- Keywords
- Africa, Antiretroviral Treatment, HIV-1, Adults, Dual maintenance therapy, Dolutegravir, Atazanavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dolutegravirDrug
One daily tablet (50mg) during 96 weeks
atazanavir boosted with ritonavirDrug
One daily tablet with atazanavir (300 mg) boosted with ritonavir (100 mg) during 96 weeks
tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovirDrug
One daily tablet with tenofovir 245 mg + lamivudine (300 mg) + efavirenz (400 mg) during 96 weeks OR One daily tablet with dolutegravir 50 mg + lamivudine (300 mg) + tenofovir (300 mg) during 96 weeks
LamivudineDrug
One daily tablet (300mg) during 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : Dual maintenance therapy DTG+3TC | Experimental | Not described Receives: Drug: dolutegravir; Drug: Lamivudine |
| Arm 2 : Dual maintenance therapy ATV/r+3TC | Experimental | Not described Receives: Drug: atazanavir boosted with ritonavir; Drug: Lamivudine |
| Arm 3 : Reference triple therapy TDF+3TC+EFV or DTG+3TC+TDF | Active comparator | Not described Receives: Drug: tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment success, as defined by using the FDA snapshot algorithm
Success : The proportion of patients who are still continuing the assigned strategy and whose last available plasma HIV-1 RNA in the the window analysis is <50 copies/ml at the end of the window analysis.
Failure : patients who have discontinued the assigned strategy or whose last available plasma HIV-1 RNA in the window analysis (90 to 102 weeks) is ≥ 50 copies/ml or with no available HIV-1 RNA in the window analysis
Measured: 90 to 102 weeks
Secondary outcomes (22)
Failure combined endpoint
Percentage of participants who reach the following combined endpoint : "new drug-resistant resistance mutations observed", "decline of at least 20% in creatinine clearance" and "occurrence of at least one grade 3-4 neuropsychiatric disorder"
Measured: Between Day 0 and Week 96
Plasma HIV-1 RNA
Evolution of plasma HIV-1 RNA
Measured: Between Day 0 and Week 96
Virological success
Evolution of the percentage of participants with virological success (VL< 50 copies/Ml)
Measured: Between Day 0 and Week 96
CD4 lymphocyte
Evolution of CD4 lymphocyte absolute count and percentage
Measured: Between Day 0 and Week 96
Virological failure and new resistance mutations
Percentage of participants with virological failure and new resistance mutations
Measured: Week 48 and Week 96
New HIV-1 drug resistance mutations
Profile of new HIV-1 drug resistance mutations observed in participants with virological failure
Measured: Week 48 and Week 96
WHO stage 3-4 morbidity
Incidence of WHO stage 3-4 morbidity ( AIDS events and non AIDS severe morbidity)
Measured: Between Day 0 and Week 96
ANRS grade 3-4 overall morbidity
Incidence of ANRS grade 3-4 overall morbidity (toxicity)
Measured: Between Day 0 and Week 96
ANRS grade 3-4 renal morbidity
Incidence of ANRS grade 3-4 renal morbidity
Measured: Between Day 0 and Week 96
ANRS grade 3-4 neurologic morbidity
Incidence of ANRS grade 3-4 neurologic morbidity
Measured: Between Day 0 and Week 96
ANRS grade 3-4 hepatic morbidity
Incidence of ANRS grade 3-4 hepatic morbidity
Measured: Between Day 0 and Week 96
Creatinine clearance
Evolution of creatinine clearance
Measured: Between Day 0 and Week 96
Grade 1,2,3 or 4 renal disorders
Evolution of the percentage of patients with grade 1,2,3 or 4 renal disorders
Measured: Between Day 0 and Week 96
Grade 1,2,3 or 4 hepatic liver disorders or abnormalities
Evolution of the percentage of patients with grade 1,2,3 or 4 hepatic liver disorders or abnormalities
Measured: Between Day 0 and Week 96
Grade 1,2,3 or 4 CNS disorders
Evolution of the percentage of patients with grade 1,2,3 or 4 CNS disorders
Measured: Between Day 0 and Week 96
Bone mineral density
Evolution of bone mineral density measured using CT bone density scan
Measured: Between Day 0 and Week 96
Adherence to treatment using a self-questionnaire
Evolution of adherence to treatments measured using a self-questionnaire
Measured: Between Day 0 and Week 96
Life quality
Evolution of quality of life measured using the ProQOL questionnaire
Measured: Between Day 0 and Week 96
Symptoms
Evolution of symptoms using the "symptoms experienced" questionnaire
Measured: Between Day 0 and Week 96
ARV drug plasma concentrations in participants with treatment failure
ARV drug plasma concentrations in participants with treatment failure
Measured: Between Day 0 and Week 96
Switched back to triple therapy
Percentage of patients on dual therapy who switched back to triple therapy
Measured: Between Day 0 and Week 96
Cost-effectiveness of the 3 ARV strategies
Cost-effectiveness of the 3 ARV strategies
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start17 Nov 2020
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- 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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Mylan Laboratories
- Responsible party
- Sponsor
- Investigators
- Serge P. Eholié, MD, MSc, Pr, Principal investigator, Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'IvoireRoland Landman, MD, Principal investigator, Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, FranceXavier Anglaret, MD, PhD, Study director, Inserm 1219, Université de Bordeaux, FrancePierre-Marie Girard, MD, PhD, Study chair, Infectious Diseases Department, University Hospital Saint Antoine, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022967
- Sponsor's protocol ID
- ANRS 12372 MODERATO
- Acronym
- MODERATO
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz (TDF+3TC+EFV) or Dolutegravir + Lamivudine + Tenofovir (DTG+3TC+TDF) in West and Central African HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT04022967
- Acronym / sponsor ID
- MODERATO / ANRS 12372 MODERATO
- Conditions
- HIV-1-infection
- Keywords
- Africa, Antiretroviral Treatment, HIV-1, Adults, Dual maintenance therapy, Dolutegravir, Atazanavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Mylan Laboratories
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 17 Jul 2019 (actual)
- 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.
MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso).
HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks.
The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks
Detailed description
In HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed (viral load < detection limit of the technique used) for at least two years: to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+ 3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks, in Cameroon, Côte d'Ivoire and Burkina Faso.
This is a trial including two strategies (dual maintenance therapy and triple reference therapy) and three ART regimens (DTG+3TC and ATV/r+3TC used in the maintenance strategy and TDF+3TC+EFV/ DTG+3TC+TDF used in the reference strategy).
The primary analysis will compare the two strategies. Secondary analyses will compare the three ART regimens two by two.
In order to make these secondary analyses possible, participants will be randomly assigned, at inclusion, to each of the three ART regimens (arm 1: DTG+3TC; arm 2: ATV/r+3TC; arm 3: TDF+3TC+EFV / DTG+3TC+TDF). The maintenance strategy will include arm 1 and 2. The reference strategy will include arm 3
Number of participants : 480 (160 in each ART regimen, ie 320 in the dual maintenance therapy strategy and 160 in the triple therapy reference strategy)
The primary endpoint is treatment success, as defined by using the FDA snapshot algorithm : patients who are still continuing the assigned strategy and whose last available plasma HIV-1 RNA in the the window analysis (90 to 102 weeks) is <50 copies/ml at the end of the window analysis (90 to 102 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Dual maintenance therapy DTG+3TC | Experimental | Drug: dolutegravir, Drug: Lamivudine |
| Arm 2 : Dual maintenance therapy ATV/r+3TC | Experimental | Drug: atazanavir boosted with ritonavir, Drug: Lamivudine |
| Arm 3 : Reference triple therapy TDF+3TC+EFV or DTG+3TC+TDF | Active comparator | Drug: tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HIV-1 infection
- Age of legal majority
- CD4 > 200 cells/mm3 at pre-inclusion
- Start first-line ART with non-nucleotide reverse transcriptase inhibitors including TDF+XTC+EFV for at least two years without a past history of virological failure, OR
- Be on TDF+XTC+EFV for at least two years then DTG+XTC+TDF without a past history of virological failure, OR
Key exclusion criteria (14 listed)
- HIV-2 infection or HIV-1+2 infection
- CD4 nadir <100 cells/mm3
- Chronic Hepatitis B (HBs Ag positive in the pre-inclusion balance)
- Ongoing active Tuberculosis
- Ongoing severe opportunistic infection
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 |
|---|---|---|
| dolutegravirOne daily tablet (50mg) during 96 weeks | Drug | Arm 1 : Dual maintenance therapy DTG+3TC |
| atazanavir boosted with ritonavirOne daily tablet with atazanavir (300 mg) boosted with ritonavir (100 mg) during 96 weeks | Drug | Arm 2 : Dual maintenance therapy ATV/r+3TC |
| tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovirOne daily tablet with tenofovir 245 mg + lamivudine (300 mg) + efavirenz (400 mg) during 96 weeks OR One daily tablet with dolutegravir 50 mg + lamivudine (300 mg) + tenofovir (300 mg) during 96 weeks | Drug | Arm 3 : Reference triple therapy TDF+3TC+EFV or DTG+3TC+TDF |
| LamivudineOne daily tablet (300mg) during 96 weeks | Drug | Arm 1 : Dual maintenance therapy DTG+3TC, Arm 2 : Dual maintenance therapy ATV/r+3TC |
Primary outcome
The treatment success, as defined by using the FDA snapshot algorithm
Time frame: 90 to 102 weeks
Success : The proportion of patients who are still continuing the assigned strategy and whose last available plasma HIV-1 RNA in the the window analysis is <50 copies/ml at the end of the window analysis. Failure : patients who have discontinued the assigned strategy or whose last available plasma HIV-1 RNA in the window analysis (90 to 102 weeks) is ≥ 50 copies/ml or with no available HIV-1 RNA in the window analysis
22 secondary outcomes
Failure combined endpoint
Time frame: Between Day 0 and Week 96
Plasma HIV-1 RNA
Time frame: Between Day 0 and Week 96
Virological success
Time frame: Between Day 0 and Week 96
CD4 lymphocyte
Time frame: Between Day 0 and Week 96
Virological failure and new resistance mutations
Time frame: Week 48 and Week 96
New HIV-1 drug resistance mutations
Time frame: Week 48 and Week 96
WHO stage 3-4 morbidity
Time frame: Between Day 0 and Week 96
ANRS grade 3-4 overall morbidity
Time frame: Between Day 0 and Week 96
ANRS grade 3-4 renal morbidity
Time frame: Between Day 0 and Week 96
ANRS grade 3-4 neurologic morbidity
Time frame: Between Day 0 and Week 96
ANRS grade 3-4 hepatic morbidity
Time frame: Between Day 0 and Week 96
Creatinine clearance
Time frame: Between Day 0 and Week 96
Grade 1,2,3 or 4 renal disorders
Time frame: Between Day 0 and Week 96
Grade 1,2,3 or 4 hepatic liver disorders or abnormalities
Time frame: Between Day 0 and Week 96
Grade 1,2,3 or 4 CNS disorders
Time frame: Between Day 0 and Week 96
Bone mineral density
Time frame: Between Day 0 and Week 96
Adherence to treatment using a self-questionnaire
Time frame: Between Day 0 and Week 96
Life quality
Time frame: Between Day 0 and Week 96
Symptoms
Time frame: Between Day 0 and Week 96
ARV drug plasma concentrations in participants with treatment failure
Time frame: Between Day 0 and Week 96
Switched back to triple therapy
Time frame: Between Day 0 and Week 96
Cost-effectiveness of the 3 ARV strategies
Time frame: Week 96
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 16 Oct 2026.
- Sponsor siteLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
HIV-1-infection, Non-Adherence, Medication
RecruitingPhase 2
Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
HIV-1 Infection
Active, not recruiting
IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention
HIV-1-infection, Unhealthy Alcohol Use
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
Serge P. Eholié, MD, MSc, Pr principal investigator
Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
Roland Landman, MD principal investigator
Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France
Xavier Anglaret, MD, PhD study director
Inserm 1219, Université de Bordeaux, France
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dolutegravir, atazanavir boosted with ritonavir and tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 5 sites in 3 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 10 inclusion and 14 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Burkina Faso, Côte d’Ivoire, Cameroon. 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?
The treatment success, as defined by using the FDA snapshot algorithm (time frame: 90 to 102 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 16 Oct 2026.