HIV-1-infectionPhase 4P25-INACTIONNCT04225325
Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI).
A Phase 4 study testing SYMTUZA, DESCOVY+DOLUTEGRAVIR and SYMTUZA+DOLUTEGRAVIR in people with HIV-1-infection, run by ADRIANO LAZZARIN, MD at 1 site in Italy.
Trial summary
Multicenter, parallel group, randomised, open label, study. Twenty-five clinical centers constituting the InAction network will participate the study. Eligible patients will be randomised in a ratio 10:10:8 to be treated with one of the three antiretroviral regimens: TDF/FTC 245 mg/200 mg single tablet QD + DRV… 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?
- SYMTUZA, DESCOVY+DOLUTEGRAVIR and SYMTUZA+DOLUTEGRAVIR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2018to 14 Jun 2021
- Phase
- Phase 4
- 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
- Subjects must be at least 18 years of age at the time of randomization, of either sex and of any race.
- Primary HIV Infection defined according to Fiebig's classification.
- Subjects must have given written informed consent and must be able to adhere to dose and visit schedules.
- Female subjects of child-bearing potential must agree to use a medically accepted method of contraception.
- Female subjects of child-bearing potential must have a negative serum beta-hCG pregnancy test at Screening, and a negative urine beta-HCG pregnancy test on Day 1 prior to dosing.
- A female, may be eligible to enter and participate in the study if she:
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- is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy;
- is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
- Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see Appendix 4 for an example listing of approved IUDs);
- Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- Approved hormonal contraception for subjects randomized to arm B (TDF/FTC + DTG)
- Approved hormonal contraception and a barrier method for subjects randomized to arm A (TDF/FTC +DRV/cobicistat) and C (TDF/FTC +DRV/cobicistat +DTG)
- Any other method with published data showing that the expected failure rate is <1% per year.
- Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP. -Approved hormonal contraception for subjects randomized to the treatment groups should be specified.
Who cannot join
- Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant.
- Subjects with active opportunistic infection or malignancy.
- Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study.
- Subjects with known liver cirrhosis.
- Subjects with any clinically significant condition or situation other than the condition being studied that, in the opinion of investigator, would interfere with the study evaluations or optimal participation.
- Subjects with allergy/sensitivity to drugs or its excipients.
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- History or presence of allergy to the study drugs or their components
- Alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN), OR ALT 3xULN and bilirubin 1.5xULN (with >35% direct bilirubin)
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Subject has creatinine clearance of <70 mL/min via Cockroft-Gault method
- Hepatic failure (Child-Plug grade C)
- Use of not modifiable concomitant drugs: carbamazepine, fenitoine, fenobarbital, rifampicine, Hypericum perforatum, dofelitide.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, MI, 20127
SILVIA NOZZA, +39.0226437961, nozza.silvia@hsr.it
MARIA RITA PARISI, +39.0226433646, parisi.mariarita@hsr.it
About this study
Official title: Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI) Treated With Multitarget Antiviral Therapy (MT-ART)
Multicenter, parallel group, randomised, open label, study. Twenty-five clinical centers constituting the InAction network will participate the study.
Eligible patients will be randomised in a ratio 10:10:8 to be treated with one of the three antiretroviral regimens:
Read more
- TDF/FTC 245 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (Arm A, standard regimen),
- TDF/FTC 245 mg/200 mg single tablet QD + DTG 50 mg QD (Arm B, standard regimen).
- TDF/FTC 245 mg/200 mg single tablet QD + DRV 800 mg /cobicistat single tablet QD + DTG 50 mg QD (Arm C, experimental regimen).
One-hundred-and-twelve PHI subjects will be recruited for this study among those attending the outpatient Clinic of Infectious Diseases, Ospedale San Raffaele and other Italian centres, involved in the INACTION network.
Read the detailed description
At Screening, potential subjects will perform serology for HIV, ELISA and Western Blot (WB), to assess Fiebig stage:
- Stage I: ELISA negative, WB negative, HIV-1 RNA positive.
- Stage II: ELISA positive for p24, WB negative.
- Stage III: ELISA positive, WB negative.
- Stage IV: ELISA positive, WB undetermined.
- Stage V: ELISA positive, WB partially positive with p31 negative.
- Stage VI: ELISA positive, WB positive, previous HIV negative test within 6 months
On Day 0 (Baseline-BL), within 0-5 days from screening, subjects will:
- perform biochemical and haematological tests, virological test (HIV-1 RNA, tropism test, genotype resistance test), immunological test (CD4+, CD4%, CD8+, CD8%, CD4/CD8).
- Perform anal and nasal brushing
- Perform microbiome
- Have behavioral survey questionnaire administered
- collect an additional sample of blood (80 mL) to perform the following evaluations:
- HIV-DNA
- T cells, B cells and DC subsets
- HLA-A, B and C
- Inflammatory markers
- Pharmacokinetic: Ctrough
- start one of the study treatment according to randomization
- Arm A: TDF/FTC 10 mg/200 mg single tablet QD +DRV /cobicistat 800 mg /150 mg single tablet QD
- Arm B: TDF/FTC 25 mg/200 mg single tablet QD +DTG 50 mg QD
- Arm C: TDF/FTC 10 mg/200 mg single tablet QD +DRV/cobicistat single tablet QD +DTG 50 mg QD
In addition, on Day 0 (Baseline-BL), subjects who will sign an additional specific informed consent:
- cerebrospinal fluid (CSF) will be collected to evaluate HIV-1 RNA
- GALT biopsies will be performed in order to allow the evaluation of viral reservoirs.
- Lymph nodes biopsies to evaluate immunological subset Following Day 0, subjects will return for visits at Weeks 2, 4, 8, 12, 24, 36 and 48 or at discontinuation.
HIV-1 RNA levels will be measured and physical examination will be performed at all the scheduled study visits CD4+, CD4%, CD8+, CD8%, CD4/CD8 will be repeated at Weeks 4, 8, 12, 24, 36, 48 or at discontinuation.
Laboratory safety parameters (complete blood count, renal function, hepatic function, lipids and glucidic profile) will be tested at Weeks 4, 8, 12, 24, 36, 48 or at discontinuation.
At week 12 and 48 or at discontinuation, an additional blood sample of 80 mL will be collected to perform the following evaluations:
- HIV-DNA and viral tropism
- T, B and DC cells subsets
- Inflammatory markers At week 2, 4, 8, 12, 24, 36, 48 or at discontinuation a blood sample of 21 mL will be collected for pharmacokinetic of drugs.
At week 12, 48 or discontinuation a stool sample will be collected to evaluate microbioma.
At week 12 and 48 anal brushing and nasal brushing will be performed to evaluate HIVDNA and pharmacokinetic analysis.
At week 12 and 48 behavioral survey questionnaire will be administered to the patient.
At week 12, or at discontinuation, in subjects who will have signed the specific additional informed consent:
- liquor will be collected to evaluate HIV-1 RNA and drugs concentration in central nervous system.
- CSF will be collected to evaluate HIV-1 RNA and drugs concentration in central nervous system.
- GALT biopsies and lymph nodes biopsy will be performed in order to allow the evaluation of viral reservoirs.
Subjects will complete the study when they will reach week 48 on their assigned regimen. At the end of the study, they will continue assigned treatment in arm A and B; if the study will show a superiority of ARM C, the patients in this arm will continue the regimen. In case of non superiority they will be switch to triple therapy. The last patient visit is the last on-study visit or date of death or lost-to follow-up or discontinuation for any reason, whichever occurs last during the conduction of the study.
Considering that the patients' enrollment will last 96 weeks, the overall length of the trial will be 144 weeks.
- Conditions
- HIV-1-infection
- Being tested
- SYMTUZA, DESCOVY+DOLUTEGRAVIR, SYMTUZA+DOLUTEGRAVIR
- Keywords
- antiretroviral drugs, HIV viral reservoir, HIV acute infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYMTUZACombination product
DESCOVY+REZOLSTA
DESCOVY+DOLUTEGRAVIRCombination product
DESCOVY+DOLUTEGRAVIR
SYMTUZA+DOLUTEGRAVIRCombination product
DESCOVY+REZOLSTA+DTG
| Study group | Role | What they receive |
|---|---|---|
| A: SYMTUZA | Active comparator | TAF/FTC 245 mg/200 mg single tablet QD +DRV /cobicistat 800 mg /150 mg single tablet QD Receives: Combination Product: SYMTUZA |
| B: DESCOVY+DOLUTEGRAVIR | Active comparator | TAF/FTC 245 mg/200 mg single tablet QD+DTG 50 mg QD Receives: Combination Product: DESCOVY+DOLUTEGRAVIR |
| C: SYMTUZA+DOLUTEGRAVIR | Experimental | TAF/FTC 245 mg/200 mg single tablet QD+DRV/cobicistat single tablet QD + +DTG 50 mg QD Receives: Combination Product: SYMTUZA+DOLUTEGRAVIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of total HIV-DNA level from baseline to 48 weeks.
The primary objective of the study is to compare the proviral DNA change in patients who started three different antiretroviral treatments.
Measured: 48 weeks
Secondary outcomes (4)
the proportion of patients with HIV-1 RNA <50 copies/mL
proportion of patients with HIV-1 RNA <50 copies/mL at week 24 and week 48;
Measured: weeks 12, 24 and 48
time to achieve undetectable viral load
HIV-1 RNA <50 copies/mL
Measured: week 12 and week 48
change in HIV-DNA
the change of total copies/mL OF HIV-DNA level from baseline to 48 weeks
Measured: week 12 and week 48
change in HIV-1 RNA in CSF
the change of total copies/mL of HIV-RNA level in cerebrospinal fluid
Measured: week 12 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start7 May 2018
- Primary completion30 Sep 2019
- Study completion14 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomised in a ratio 10:10:8 to be treated with one of the three antiretroviral regimens: * TDF/FTC 245 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (Arm A, standard regimen), * TDF/FTC 245 mg/200 mg single tablet QD + DTG 50 mg QD (Arm B, standard regimen). * TDF/FTC 245 mg/200 mg single tablet QD + DRV 800 mg /cobicistat single tablet QD + DTG 50 mg QD (Arm C, experimental regimen).
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADRIANO LAZZARIN, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Responsible party
- Sponsor-investigator, ADRIANO LAZZARIN, MD, Ospedale San Raffaele
- Investigators
- GIUSEPPE TAMBUSSI, Study chair, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225325
- Sponsor's protocol ID
- P25-INACTION
- Acronym
- P25-INACTION
- Status last verified
- Jan 2020
- First submitted
- 16 Sep 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruzzesi E, Gabrieli A, Bernasconi D, Marchetti G, Calcagno A, Ripamonti D, Antinori A, Squillace N, Cingolani A, Muscatello A, Bandera A, Gori A, Rusconi S, Nozza S; INACTION Study Group. HIV-DNA decrease during treatment in primary HIV-1 infection with three different drug regimens: Italian Network of Acute HIV Infection (INACTION) clinical trial. J Med Virol. 2023 Sep;95(9):e29114. doi: 10.1002/jmv.29114.
PubMed 37752816
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI) Treated With Multitarget Antiviral Therapy (MT-ART)
- ClinicalTrials.gov ID
- NCT04225325
- Acronym / sponsor ID
- P25-INACTION / P25-INACTION
- Conditions
- HIV-1-infection
- Keywords
- antiretroviral drugs, HIV viral reservoir, HIV acute infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- ADRIANO LAZZARIN, MDUniversity, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 14 Jun 2021 (estimated)
- First posted
- 13 Jan 2020 (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.
Multicenter, parallel group, randomised, open label, study. Twenty-five clinical centers constituting the InAction network will participate the study.
Eligible patients will be randomised in a ratio 10:10:8 to be treated with one of the three antiretroviral regimens:
- TDF/FTC 245 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (Arm A, standard regimen),
- TDF/FTC 245 mg/200 mg single tablet QD + DTG 50 mg QD (Arm B, standard regimen).
- TDF/FTC 245 mg/200 mg single tablet QD + DRV 800 mg /cobicistat single tablet QD + DTG 50 mg QD (Arm C, experimental regimen).
One-hundred-and-twelve PHI subjects will be recruited for this study among those attending the outpatient Clinic of Infectious Diseases, Ospedale San Raffaele and other Italian centres, involved in the INACTION network.
Detailed description
At Screening, potential subjects will perform serology for HIV, ELISA and Western Blot (WB), to assess Fiebig stage:
- Stage I: ELISA negative, WB negative, HIV-1 RNA positive.
- Stage II: ELISA positive for p24, WB negative.
- Stage III: ELISA positive, WB negative.
- Stage IV: ELISA positive, WB undetermined.
- Stage V: ELISA positive, WB partially positive with p31 negative.
- Stage VI: ELISA positive, WB positive, previous HIV negative test within 6 months
On Day 0 (Baseline-BL), within 0-5 days from screening, subjects will:
- perform biochemical and haematological tests, virological test (HIV-1 RNA, tropism test, genotype resistance test), immunological test (CD4+, CD4%, CD8+, CD8%, CD4/CD8).
- Perform anal and nasal brushing
- Perform microbiome
- Have behavioral survey questionnaire administered
- collect an additional sample of blood (80 mL) to perform the following evaluations:
- HIV-DNA
- T cells, B cells and DC subsets
- HLA-A, B and C
- Inflammatory markers
- Pharmacokinetic: Ctrough
- start one of the study treatment according to randomization
- Arm A: TDF/FTC 10 mg/200 mg single tablet QD +DRV /cobicistat 800 mg /150 mg single tablet QD
- Arm B: TDF/FTC 25 mg/200 mg single tablet QD +DTG 50 mg QD
- Arm C: TDF/FTC 10 mg/200 mg single tablet QD +DRV/cobicistat single tablet QD +DTG 50 mg QD
In addition, on Day 0 (Baseline-BL), subjects who will sign an additional specific informed consent:
- cerebrospinal fluid (CSF) will be collected to evaluate HIV-1 RNA
- GALT biopsies will be performed in order to allow the evaluation of viral reservoirs.
- Lymph nodes biopsies to evaluate immunological subset Following Day 0, subjects will return for visits at Weeks 2, 4, 8, 12, 24, 36 and 48 or at discontinuation.
HIV-1 RNA levels will be measured and physical examination will be performed at all the scheduled study visits CD4+, CD4%, CD8+, CD8%, CD4/CD8 will be repeated at Weeks 4, 8, 12, 24, 36, 48 or at discontinuation.
Laboratory safety parameters (complete blood count, renal function, hepatic function, lipids and glucidic profile) will be tested at Weeks 4, 8, 12, 24, 36, 48 or at discontinuation.
At week 12 and 48 or at discontinuation, an additional blood sample of 80 mL will be collected to perform the following evaluations:
- HIV-DNA and viral tropism
- T, B and DC cells subsets
- Inflammatory markers At week 2, 4, 8, 12, 24, 36, 48 or at discontinuation a blood sample of 21 mL will be collected for pharmacokinetic of drugs.
At week 12, 48 or discontinuation a stool sample will be collected to evaluate microbioma.
At week 12 and 48 anal brushing and nasal brushing will be performed to evaluate HIVDNA and pharmacokinetic analysis.
At week 12 and 48 behavioral survey questionnaire will be administered to the patient.
At week 12, or at discontinuation, in subjects who will have signed the specific additional informed consent:
- liquor will be collected to evaluate HIV-1 RNA and drugs concentration in central nervous system.
- CSF will be collected to evaluate HIV-1 RNA and drugs concentration in central nervous system.
- GALT biopsies and lymph nodes biopsy will be performed in order to allow the evaluation of viral reservoirs.
Subjects will complete the study when they will reach week 48 on their assigned regimen. At the end of the study, they will continue assigned treatment in arm A and B; if the study will show a superiority of ARM C, the patients in this arm will continue the regimen. In case of non superiority they will be switch to triple therapy. The last patient visit is the last on-study visit or date of death or lost-to follow-up or discontinuation for any reason, whichever occurs last during the conduction of the study.
Considering that the patients' enrollment will last 96 weeks, the overall length of the trial will be 144 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Eligible patients will be randomised in a ratio 10:10:8 to be treated with one of the three antiretroviral regimens: * TDF/FTC 245 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (Arm A, standard regimen), * TDF/FTC 245 mg/200 mg single tablet QD + DTG 50 mg QD (Arm B, standard regimen). * TDF/FTC 245 mg/200 mg single tablet QD + DRV 800 mg /cobicistat single tablet QD + DTG 50 mg QD (Arm C, experimental regimen).
| Arm | Type | Receives |
|---|---|---|
| A: SYMTUZA | Active comparator | Combination Product: SYMTUZATAF/FTC 245 mg/200 mg single tablet QD +DRV /cobicistat 800 mg /150 mg single tablet QD |
| B: DESCOVY+DOLUTEGRAVIR | Active comparator | Combination Product: DESCOVY+DOLUTEGRAVIRTAF/FTC 245 mg/200 mg single tablet QD+DTG 50 mg QD |
| C: SYMTUZA+DOLUTEGRAVIR | Experimental | Combination Product: SYMTUZA+DOLUTEGRAVIRTAF/FTC 245 mg/200 mg single tablet QD+DRV/cobicistat single tablet QD + +DTG 50 mg QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must be at least 18 years of age at the time of randomization, of either sex and of any race.
- Primary HIV Infection defined according to Fiebig's classification.
- Subjects must have given written informed consent and must be able to adhere to dose and visit schedules.
- Female subjects of child-bearing potential must agree to use a medically accepted method of contraception.
- Female subjects of child-bearing potential must have a negative serum beta-hCG pregnancy test at Screening, and a negative urine beta-HCG pregnancy test on Day 1 prior to dosing.
Key exclusion criteria (13 listed)
- Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant.
- Subjects with active opportunistic infection or malignancy.
- Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study.
- Subjects with known liver cirrhosis.
- Subjects with any clinically significant condition or situation other than the condition being studied that, in the opinion of investigator, would interfere with the study evaluations or optimal participation.
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 |
|---|---|---|
| SYMTUZADESCOVY+REZOLSTA | Combination product | A: SYMTUZA |
| DESCOVY+DOLUTEGRAVIRDESCOVY+DOLUTEGRAVIR | Combination product | B: DESCOVY+DOLUTEGRAVIR |
| SYMTUZA+DOLUTEGRAVIRDESCOVY+REZOLSTA+DTG | Combination product | C: SYMTUZA+DOLUTEGRAVIR |
Primary outcome
the change of total HIV-DNA level from baseline to 48 weeks.
Time frame: 48 weeks
The primary objective of the study is to compare the proviral DNA change in patients who started three different antiretroviral treatments.
4 secondary outcomes
the proportion of patients with HIV-1 RNA <50 copies/mL
Time frame: weeks 12, 24 and 48
time to achieve undetectable viral load
Time frame: week 12 and week 48
change in HIV-DNA
Time frame: week 12 and week 48
change in HIV-1 RNA in CSF
Time frame: week 12 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 37752816Bruzzesi E, Gabrieli A, Bernasconi D, Marchetti G, Calcagno A, Ripamonti D, Antinori A, Squillace N, Cingolani A, Muscatello A, Bandera A, Gori A, Rusconi S, Nozza S; INACTION Study Group. HIV-DNA decrease during treatment in primary HIV-1 infection with three different drug regimens: Italian Network of Acute HIV Infection (INACTION) clinical trial. J Med Virol. 2023 Sep;95(9):e29114. doi: 10.1002/jmv.29114.
- Individual participant dataSharing planned: No
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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.
GIUSEPPE TAMBUSSI study chair
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SYMTUZA, DESCOVY+DOLUTEGRAVIR and SYMTUZA+DOLUTEGRAVIR in people with HIV-1-infection, run by ADRIANO LAZZARIN, MD at 1 site in Italy.
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 16 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SILVIA NOZZA (0226437961 ext. +39, nozza.silvia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of total HIV-DNA level from baseline to 48 weeks. (time frame: 48 weeks). 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 NCT04225325, which also lists 1 linked publication.
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 13 Jan 2020.