HIV-1 InfectionPhase 2ATALOWNCT02473328
Study Evaluating the Efficacy of a Reduced Dose Atazanavir in HIV-1-infected Patients
A Phase 2 study testing Atazanavir 200 mg/r in people with HIV-1 Infection, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
Trial summary
The goal of antiretroviral therapy should be maintaining undetectable plasma viral load, only present condition to prevent the progression of the disease, improve immune restoration and prevent the emergence of viral resistance mutations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Atazanavir 200 mg/r
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2017
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented HIV-1 infection.
- Age ≥ 18 years
- Plasma HIV-RNA level ≤ 50 copies/mL during the last 24 months prior to screening visit (W-4), documented by at least 4 time-points
- Stable antiretroviral treatment with 2 NRTI + ATV/r 300/100 for at least 6 month
- CD4+ lymphocytes > 300 cells/mm3
- Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential
- Signed informed consent
- Patient affiliated or beneficiary of a national insurance scheme (article L1121-11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)
Who cannot join
- HIV-2 infection.
- Patient with resistant mutation for ATV and/or NRTI used on the available genotypic test
- Concomitant treatment using one or more molecules interacting with hepatic cytochromes
- Ongoing cancer. Patients with cancer considered cured for at least six months may be included.
- Active viral hepatitis C requiring a specific treatment during the 48 weeks of the trial
- hemodialysis patients
Show all 12Show fewer
- Pregnant women, breastfeeding women or women wishing to be pregnant during the study period
- Patient with a history of non-compliance or irregular follow-up
- Subjects under "Backup justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
- Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase
- All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
- Non-attendance which could impede the trial participation (travel abroad, moving, impending transfer...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-comparative Phase II Open Study Evaluating the Efficacy of a Reduced Dose Atazanavir / Ritonavir 200/100 mg + 2 NRTI in HIV-1-infected Patients With Virological Success With Atazanavir / Ritonavir 300/100 mg + 2 NRTI
The goal of antiretroviral therapy should be maintaining undetectable plasma viral load, only present condition to prevent the progression of the disease, improve immune restoration and prevent the emergence of viral resistance mutations. In addition to the individual benefit, antiretroviral treatment reduces the transmission of HIV from an infected person to sexual partners. There is to date no alternative strategy to antiretroviral treatment and antiretroviral therapy, even extended, does not allow viral eradication.
The need to maintain antiretroviral therapy for life raises the long-term safety concerns of it, even with the latest molecules. Also, one of the key issues in clinical research is whether after reaching undetectable viral load, antiretroviral treatment can be reduced in order to reduce exposure to molecules. Indeed, this treatment of "maintenance" could potentially need a smaller antiviral potency. On the other hand, reduction of antiretroviral treatment reduces costs, an important consideration in light of new global recommendations of treatment for all patients with T-cells CD4 below 500 / mm3.
Read more
The alleviation of antiretroviral therapy is to either reduce the number of molecules by making monotherapies or dual therapy, or to realize or intermittent treatment is to reduce the doses of molecules such as randomized ENCORE -1 showing the equivalence of a dose of Efavirenz 400mg instead of 600mg in naive patients.
Atalow study has the sense to lower the dose of Atazanavir / Ritonavir in combination with two NRTI to reduce exposure to this molecule and its cost while maintaining an undetectable viral load.
Read the detailed description
Protease inhibitors (PIs) are key treatments in the current therapeutic strategy. They have major qualities such as their antiviral potency and high genetic barrier.
However, their long-term use is associated with gastrointestinal side effects, metabolic disorders (lipid, carbohydrate, lipohypertrophy) and cardiovascular comorbidities, renal and bone. The decrease in IP doses would reduce this predominantly concentration-dependent toxicity.
Atazanavir (Reyataz) was the first protease inhibitor once daily approved in 2003 for the treatment of HIV patients. Its favorable safety profile, ease of making and effectiveness have made treatment widely used and recommended first line. Atazanavir is recommended in Europe in naïve patient at the 300 mg dose once daily boosted with ritonavir 100 mg and in the pretreated patient at the 300 mg boosted with 100mg ritonavir or a dose of 400 no boosted mg in combination with two other antiretroviral drugs.
After oral administration, atazanavir is rapidly absorbed with improved variable bioavailability with food intake (40% increase in Cmin) and dependent on the gastric potential hydrogen (pH). Atazanavir is highly bound to plasma proteins (86%) and is largely metabolised by the isoform 3A4 (CYP3A4) cytochrome P450. There is great variability in the pharmacokinetics of atazanavir between patients due to inter-individual variability in the expression and function of CYP3A4. Co-administration of ritonavir increased 11.9 times Cmin and decreases the interindividual variability. The major effect of ritonavir is to decrease hepatic clearance of atazanavir. Its half-life of elimination is 8.6 hours when administered at 300 mg with 100 mg of ritonavir. 90% inhibitory concentration of atazanavir adjusted to the plasma protein binding (PBA EC90) is 14ng / ml. At the standard dose of 300 mg taken with 100 mg ritonavir once daily, the mean trough concentration at steady state is according to research from 526 ng / ml and 862 ng / ml in HIV patients. Residual therapeutic levels (Cmin) must be greater than 150 ng / ml. The relationship between the residual plasma concentrations and virologic response was demonstrated in the naive patient pharmacokinetic substudy BMS 089.
If the inhibitor atazanavir is best tolerated on lipid map protease is responsible for specific side effects such as hyperbilirubinemia and nephrolithiasis, concentration-dependent side effects. Indeed, atazanavir is responsible for a reversible elevation of unconjugated bilirubin, inhibiting glucuronide conjugation bilirubin by UGT1A1. This effect, not easily concealed by the patient, is an important and annoying side effects that may interfere with treatment adherence. This hyperbilirubinemia is concentration-dependent, with elevated bilirubin most common grade 3-4, atazanavir C min is greater than 760 ng / ml (600 to 850 ng / ml according to studies).
No boosted atazanavir may be used but with caution. Indeed, its use should be avoided in patients with a history of failure or virological resistance mutations in a patient with poor adherence and in patients taking other drugs that could interfere with atazanavir. Pharmacokinetic studies at a dose of 400 mg without ritonavir showed a concentration below the expected minimum concentration of 150 mg / l in 60% of cases. In addition, the use of no boosted atazanavir with tenofovir has been little studied and requires close monitoring pharmacological given the interaction between these two molecules (decrease of approximately 25% of the concentration of atazanavir when without ritonavir in combination with tenofovir. Finally, in the INDUMA study, there was no virologic rebounds in this strategy.
Monotherapy atazanavir is not recommended in light of studies showing virological failures under this strategy.
The evaluation of atazanavir / r 200/100 in healthy patient presented at CROI meeting in 2001 in Phase II studies showed a mean Cmin 378 ng / ml (SD = 286 EC).
A retrospective cohort study in 14 Thai patients with virologic success in switched to atazanavir / r 200/100 showed maintenance of a CV less than 50 copies / ml over a median follow-up 68 weeks (range 12-165 weeks). Five of the patients had a dose of atazanavir Cmin had greater than 150 ng / ml (mean Cmin = 572 ng / ml). The lipid profile was improved but not significantly.
A pharmacokinetic study of 22 Thai patients on atazanavir / r 300/100 in switched to atazanavir / r 200/100 2 NRTIs showed minimum concentrations reduced by 48.6% remaining above the minimum therapeutic concentration of 150 ng / ml (mean Cmin = 700 ng / ml EC = 470).
A case study conducted in 14 Italian patients (10 Caucasian and 4 of African origin) with virologic suppression (CV below 50 copies / ml) with atazanavir / r 300/100 mg + 2 NRTI showed a maintenance of viral efficacy after the switch to atazanavir / r 200/100 on a 1 year average follow-up. Atazanavir C min was above Cmin for all except 2 patients (whose viral load remained below 50 copies / ml), with a mean Cmin 713ng / ml. Bilirubin decreased after the switch.
Recently, a pharmacokinetic simulation study was performed in a majority of Caucasian patients for atazanavir / r doses at 300/50 mg, 200/50 mg and 200/100 mg. The lowest concentrations of atazanavir after dose reduction 200/100 averaged 520 ng / ml (EC = 448) and all remained above the recommended Cmin.
In total, these four dose reduction studies of atazanavir / r 200/100 in treatment-experienced patients with virologic average Cmin were between 520 and 713ng / ml, well above the therapeutic Cmin.
The decrease in atazanavir dose showed a significant decrease of serum bilirubin 14.88μmol / l after 2 weeks.
This test is within the overall reflection optimization of antiretroviral therapy.
In view of the existing data of Pharmacology and few data Italian and Thai in switched patients to atazanavir / r 200/100 mg, the ATALOW study hypothesizes that a lower dose of atazanavir / r 200 / 100 mg is able to maintain an undetectable viral load in treatment-experienced patients with virologic success.
The expected benefits of the reduction in the dose of atazanavir / r 200/100 mg + would be:
- A better tolerance especially in terms of bilirubin
- A more robust strategy that using no boosted atazanavir with the possibility of using tenofovir in combination NRTI.
- The same simplicity taking once a day
- Reduced costs (2,730 euros less per patient per year).
- Conditions
- HIV-1 Infection
- Being tested
- Atazanavir 200 mg/r
- Keywords
- dose reduction study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir 200 mg/rDrug
Also called ritonavir 100mg
- In patients signed an informed consent and meeting all the eligibility criteria at the time of the run-in (S-4),
- switch of antiretroviral therapy Atazanavir 300 mg/ritonavir 100 mg once a day to Atazanavir 200 mg/ritonavir 100 mg once a day without changing the combination of 2 NRTIs associated.
The administration will be done once a day orally for 48 weeks.
The usual recommended dose of atazanavir is 300 mg once daily with 100 mg of ritonavir once daily with food. Ritonavir acts by potentiating the pharmacokinetics of atazanavir.
| Study group | Role | What they receive |
|---|---|---|
| non comparative open study | Experimental | In patients signed an informed consent and meeting all the eligibility criteria at the time of the run-in (S-4), switch of antiretroviral therapy Atazanavir 300 mg/ritonavir 100 mg once a day to Atazanavir 200 mg/ritonavir 100 mg once a day without changing the combination of 2 NRTIs associated.
The administration will be done once a day orally for 48 weeks. Receives: Drug: Atazanavir 200 mg/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of effectiveness assessed by maintaining undetectable plasma HIV viral load (viral load ≤ 50 copies / ml) during the all period of this study of treatment with ATV / r 200/100 mg + 2 NRTIs, for all patients.
Measured: one year
Measure of safety (adverse events)
Number of participant with adverse events
Measured: one year
Measure of tolerability assessed by number of patient interrupting the study treatment for virological failure
Measured: one year
Measure of effectiveness assessed by number of patient maintaining a target trough plasma concentration of atazanavir associated to efficacy:
Residual plasma concentrations of ATV / r (Dates and last dose of antiretroviral schedules and the association or not with food ) will be performed at day 0 before changing dose reduction of atazanavir, week 12 and week 24 for all patients.
Measured: one year
Measure of effectiveness assessed in patient with virological failure number of patient dysplaing HIV strains with mutations associated to treatment resistance
Measured: one year
Measure of tolerability assessed by number of patient interrupting the study treatment for in tolerance
Measured: one year
Measure of tolerability assessed by quantification of bilirubinemia
Measured: one year
Measure of tolerability assessed by quantification of creatininemia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR S 1136
- Responsible party
- Sponsor
- Investigators
- Christine Katlama, MD, Principal investigator, Groupe Hospitalier Pitie-SalpetriereClaudine Duvivier, MD, Principal investigator, Hôpital Necker-Enfants MaladesYazdan Yazdanpanah, MD, Principal investigator, Groupe hospitalier Bichat-Claude Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473328
- Sponsor's protocol ID
- CREPATS 003
- Acronym
- ATALOW
- Status last verified
- Aug 2018
- First submitted
- 27 May 2015
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-comparative Phase II Open Study Evaluating the Efficacy of a Reduced Dose Atazanavir / Ritonavir 200/100 mg + 2 NRTI in HIV-1-infected Patients With Virological Success With Atazanavir / Ritonavir 300/100 mg + 2 NRTI
- ClinicalTrials.gov ID
- NCT02473328
- Acronym / sponsor ID
- ATALOW / CREPATS 003
- Conditions
- HIV-1 Infection
- Keywords
- dose reduction study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Collaborators
- INSERM UMR S 1136
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Jun 2015 (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 goal of antiretroviral therapy should be maintaining undetectable plasma viral load, only present condition to prevent the progression of the disease, improve immune restoration and prevent the emergence of viral resistance mutations. In addition to the individual benefit, antiretroviral treatment reduces the transmission of HIV from an infected person to sexual partners. There is to date no alternative strategy to antiretroviral treatment and antiretroviral therapy, even extended, does not allow viral eradication.
The need to maintain antiretroviral therapy for life raises the long-term safety concerns of it, even with the latest molecules. Also, one of the key issues in clinical research is whether after reaching undetectable viral load, antiretroviral treatment can be reduced in order to reduce exposure to molecules. Indeed, this treatment of "maintenance" could potentially need a smaller antiviral potency. On the other hand, reduction of antiretroviral treatment reduces costs, an important consideration in light of new global recommendations of treatment for all patients with T-cells CD4 below 500 / mm3.
The alleviation of antiretroviral therapy is to either reduce the number of molecules by making monotherapies or dual therapy, or to realize or intermittent treatment is to reduce the doses of molecules such as randomized ENCORE -1 showing the equivalence of a dose of Efavirenz 400mg instead of 600mg in naive patients.
Atalow study has the sense to lower the dose of Atazanavir / Ritonavir in combination with two NRTI to reduce exposure to this molecule and its cost while maintaining an undetectable viral load.
Detailed description
Protease inhibitors (PIs) are key treatments in the current therapeutic strategy. They have major qualities such as their antiviral potency and high genetic barrier.
However, their long-term use is associated with gastrointestinal side effects, metabolic disorders (lipid, carbohydrate, lipohypertrophy) and cardiovascular comorbidities, renal and bone. The decrease in IP doses would reduce this predominantly concentration-dependent toxicity.
Atazanavir (Reyataz) was the first protease inhibitor once daily approved in 2003 for the treatment of HIV patients. Its favorable safety profile, ease of making and effectiveness have made treatment widely used and recommended first line. Atazanavir is recommended in Europe in naïve patient at the 300 mg dose once daily boosted with ritonavir 100 mg and in the pretreated patient at the 300 mg boosted with 100mg ritonavir or a dose of 400 no boosted mg in combination with two other antiretroviral drugs.
After oral administration, atazanavir is rapidly absorbed with improved variable bioavailability with food intake (40% increase in Cmin) and dependent on the gastric potential hydrogen (pH). Atazanavir is highly bound to plasma proteins (86%) and is largely metabolised by the isoform 3A4 (CYP3A4) cytochrome P450. There is great variability in the pharmacokinetics of atazanavir between patients due to inter-individual variability in the expression and function of CYP3A4. Co-administration of ritonavir increased 11.9 times Cmin and decreases the interindividual variability. The major effect of ritonavir is to decrease hepatic clearance of atazanavir. Its half-life of elimination is 8.6 hours when administered at 300 mg with 100 mg of ritonavir. 90% inhibitory concentration of atazanavir adjusted to the plasma protein binding (PBA EC90) is 14ng / ml. At the standard dose of 300 mg taken with 100 mg ritonavir once daily, the mean trough concentration at steady state is according to research from 526 ng / ml and 862 ng / ml in HIV patients. Residual therapeutic levels (Cmin) must be greater than 150 ng / ml. The relationship between the residual plasma concentrations and virologic response was demonstrated in the naive patient pharmacokinetic substudy BMS 089.
If the inhibitor atazanavir is best tolerated on lipid map protease is responsible for specific side effects such as hyperbilirubinemia and nephrolithiasis, concentration-dependent side effects. Indeed, atazanavir is responsible for a reversible elevation of unconjugated bilirubin, inhibiting glucuronide conjugation bilirubin by UGT1A1. This effect, not easily concealed by the patient, is an important and annoying side effects that may interfere with treatment adherence. This hyperbilirubinemia is concentration-dependent, with elevated bilirubin most common grade 3-4, atazanavir C min is greater than 760 ng / ml (600 to 850 ng / ml according to studies).
No boosted atazanavir may be used but with caution. Indeed, its use should be avoided in patients with a history of failure or virological resistance mutations in a patient with poor adherence and in patients taking other drugs that could interfere with atazanavir. Pharmacokinetic studies at a dose of 400 mg without ritonavir showed a concentration below the expected minimum concentration of 150 mg / l in 60% of cases. In addition, the use of no boosted atazanavir with tenofovir has been little studied and requires close monitoring pharmacological given the interaction between these two molecules (decrease of approximately 25% of the concentration of atazanavir when without ritonavir in combination with tenofovir. Finally, in the INDUMA study, there was no virologic rebounds in this strategy.
Monotherapy atazanavir is not recommended in light of studies showing virological failures under this strategy.
The evaluation of atazanavir / r 200/100 in healthy patient presented at CROI meeting in 2001 in Phase II studies showed a mean Cmin 378 ng / ml (SD = 286 EC).
A retrospective cohort study in 14 Thai patients with virologic success in switched to atazanavir / r 200/100 showed maintenance of a CV less than 50 copies / ml over a median follow-up 68 weeks (range 12-165 weeks). Five of the patients had a dose of atazanavir Cmin had greater than 150 ng / ml (mean Cmin = 572 ng / ml). The lipid profile was improved but not significantly.
A pharmacokinetic study of 22 Thai patients on atazanavir / r 300/100 in switched to atazanavir / r 200/100 2 NRTIs showed minimum concentrations reduced by 48.6% remaining above the minimum therapeutic concentration of 150 ng / ml (mean Cmin = 700 ng / ml EC = 470).
A case study conducted in 14 Italian patients (10 Caucasian and 4 of African origin) with virologic suppression (CV below 50 copies / ml) with atazanavir / r 300/100 mg + 2 NRTI showed a maintenance of viral efficacy after the switch to atazanavir / r 200/100 on a 1 year average follow-up. Atazanavir C min was above Cmin for all except 2 patients (whose viral load remained below 50 copies / ml), with a mean Cmin 713ng / ml. Bilirubin decreased after the switch.
Recently, a pharmacokinetic simulation study was performed in a majority of Caucasian patients for atazanavir / r doses at 300/50 mg, 200/50 mg and 200/100 mg. The lowest concentrations of atazanavir after dose reduction 200/100 averaged 520 ng / ml (EC = 448) and all remained above the recommended Cmin.
In total, these four dose reduction studies of atazanavir / r 200/100 in treatment-experienced patients with virologic average Cmin were between 520 and 713ng / ml, well above the therapeutic Cmin.
The decrease in atazanavir dose showed a significant decrease of serum bilirubin 14.88μmol / l after 2 weeks.
This test is within the overall reflection optimization of antiretroviral therapy.
In view of the existing data of Pharmacology and few data Italian and Thai in switched patients to atazanavir / r 200/100 mg, the ATALOW study hypothesizes that a lower dose of atazanavir / r 200 / 100 mg is able to maintain an undetectable viral load in treatment-experienced patients with virologic success.
The expected benefits of the reduction in the dose of atazanavir / r 200/100 mg + would be:
- A better tolerance especially in terms of bilirubin
- A more robust strategy that using no boosted atazanavir with the possibility of using tenofovir in combination NRTI.
- The same simplicity taking once a day
- Reduced costs (2,730 euros less per patient per year).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non comparative open study | Experimental | Drug: Atazanavir 200 mg/rIn patients signed an informed consent and meeting all the eligibility criteria at the time of the run-in (S-4), switch of antiretroviral therapy Atazanavir 300 mg/ritonavir 100 mg once a day to Atazanavir 200 mg/ritonavir 100 mg once a day without changing the combination of 2 NRTIs associated. The administration will be done once a day orally for 48 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Documented HIV-1 infection.
- Age ≥ 18 years
- Plasma HIV-RNA level ≤ 50 copies/mL during the last 24 months prior to screening visit (W-4), documented by at least 4 time-points
- Stable antiretroviral treatment with 2 NRTI + ATV/r 300/100 for at least 6 month
- CD4+ lymphocytes > 300 cells/mm3
Key exclusion criteria (12 listed)
- HIV-2 infection.
- Patient with resistant mutation for ATV and/or NRTI used on the available genotypic test
- Concomitant treatment using one or more molecules interacting with hepatic cytochromes
- Ongoing cancer. Patients with cancer considered cured for at least six months may be included.
- Active viral hepatitis C requiring a specific treatment during the 48 weeks of the trial
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 |
|---|---|---|
| Atazanavir 200 mg/rAlso: ritonavir 100mg1. In patients signed an informed consent and meeting all the eligibility criteria at the time of the run-in (S-4), 2. switch of antiretroviral therapy Atazanavir 300 mg/ritonavir 100 mg once a day to Atazanavir 200 mg/ritonavir 100 mg once a day without changing the combination of 2 NRTIs associated. The administration will be done once a day orally for 48 weeks. The usual recommended dose of atazanavir is 300 mg once daily with 100 mg of ritonavir once daily with food. Ritonavir acts by potentiating the pharmacokinetics of atazanavir. | Drug | non comparative open study |
Primary outcome
Measure of effectiveness assessed by maintaining undetectable plasma HIV viral load (viral load ≤ 50 copies / ml) during the all period of this study of treatment with ATV / r 200/100 mg + 2 NRTIs, for all patients.
Time frame: one year
Measure of safety (adverse events)
Time frame: one year
Number of participant with adverse events
Measure of tolerability assessed by number of patient interrupting the study treatment for virological failure
Time frame: one year
Measure of effectiveness assessed by number of patient maintaining a target trough plasma concentration of atazanavir associated to efficacy:
Time frame: one year
Residual plasma concentrations of ATV / r (Dates and last dose of antiretroviral schedules and the association or not with food ) will be performed at day 0 before changing dose reduction of atazanavir, week 12 and week 24 for all patients.
Measure of effectiveness assessed in patient with virological failure number of patient dysplaing HIV strains with mutations associated to treatment resistance
Time frame: one year
Measure of tolerability assessed by number of patient interrupting the study treatment for in tolerance
Time frame: one year
Measure of tolerability assessed by quantification of bilirubinemia
Time frame: one year
Measure of tolerability assessed by quantification of creatininemia
Time frame: one year
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 21 Aug 2018.
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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.
Christine Katlama, MD principal investigator
Groupe Hospitalier Pitie-Salpetriere
Claudine Duvivier, MD principal investigator
Hôpital Necker-Enfants Malades
Yazdan Yazdanpanah, MD principal investigator
Groupe hospitalier Bichat-Claude Bernard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atazanavir 200 mg/r in people with HIV-1 Infection, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida 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 8 inclusion and 12 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 21 Aug 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Measure of effectiveness assessed by maintaining undetectable plasma HIV viral load (viral load ≤ 50 copies / ml) during the all period of this study of treatment with ATV / r 200/100 mg + 2 NRTIs, for all patients. (time frame: one year). The study lists 8 primary outcomes in all. 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 21 Aug 2018.