HIV-1-infectionPhase 1/2LUNANCT03525730
LRAs United as a Novel Anti-HIV Strategy.
A Phase 1/2 study testing Valproic Acid and Pyrimethamine in people with HIV-1-infection, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
A translational proof of concept study in humans on the primary research question whether novel anti-human immunodeficiency virus (HIV) latency strategies, including a BAF inhibitor and a histone deacetylase inhibitor, result in HIV reservoir reduction in HIV patients on antiretroviral therapy. 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?
- Valproic Acid and Pyrimethamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Apr 2018to 1 Oct 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected patients ≥18 years.
- World Health Organization (WHO) performance status 0 or 1.
- Confirmed HIV-1 infection by 4th generation ELISA, Western Blot or PCR.
- Wild type HIV infection or polymorphisms associated with at highest low-level resistance to any class of ART according to Stanford HIV drug resistance database. Transmitted mutations and acquired mutations due to virological failure associated with resistance of at highest low-level resistance are allowed.
- On cART.
- Current plasma HIV-RNA <50 copies/mL for at least 365 days and measured on at least 2 occasions of which at least 1 must be obtained within 365 and 90 days prior to study entry.
- Current CD4 T-cell count at study entry of ≥200 cells/mm3.
- Pre-cART HIV-RNA ≥10.000 copies/mL.
Who cannot join
- Previous virological failure, defined as either acquired resistance mutations (>low level resistance) on cART or HIV-RNA >1000 copies/mL on two consecutive measurements during cART.
- Uncontrolled hepatitis B or C co-infection. For hepatitis B: patients should be vaccinated, or on pre-exposure prophylaxis through the use of lamivudine/emtricitabine or tenofovir in their combination ART. Otherwise, standard serological testing should be available within the last 365 days for homosexual HIV positive men. For non-homosexual HIV positive persons, there should be at least one negative hepatitis B test (either by serology or PCR). For homosexual HIV positive men, a negative hepatitis C immunoglobulin G, hepatitis C (HCV) antigen, blot or HCV-RNA PCR should be available within the previous 365 days. For non-homosexual HIV positive persons, there should be at least one negative hepatitis C test (either IgG, blot or PCR) available.
- Prior exposure to any HDACi, BAFi or other known LRA.
- Prior exposure to cytotoxic myeloablative chemotherapy for hematological malignancies during cART.
- Concurrent exposure to strong interacting medication on glucuronidation.
- Exposure within 90 days prior to study entry to immunomodulators, cytokines, systemic antifungals, dexamethasone, vitamin K antagonists, anti-epileptics, antipsychotics, carbapenems, mefloquine, colestyramine, Any documented opportunistic infection related to HIV in the last 90 days.
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- Inadequate blood counts, renal and hepatic function tests
- Haemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females), leucocytes <2.5 x109/L, absolute neutrophil count <1000 cells/mm3, thrombocytes <100 x109/L, international standardized ratio >1.6, activated partial thromboplastin time >40 seconds.
- Estimated glomerular filtration rate <50 mL/min (CKD-EPI),
- Alanine aminotransferase or total bilirubin >2.5x upper limit of normal.
- All laboratory values must be obtained within 42 days prior to the baseline visit.
- Megaloblastic anemia due to folate deficiency.
- Pancreatitis in last 6 months, or chronic pancreatitis.
- Active malignancy during the past year with the exception of basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi Sarcoma treated with cART alone, or other indolent malignancies.
- Females in the reproductive age cannot participate. Males cannot participate if they refuse to abstain from sex or condom use in serodiscordant sexual contact during the study, except if their sexual partner(s) use pre-exposure prophylaxis.
- Patients with active substance abuse or registered allergies to the investigational medical products.
- Last, any other condition (familial, psychological, sociological, geographical) which in the investigator's opinion poses an unacceptable risk or would hamper compliance with the study protocol and follow up schedule, will prohibit participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LRAs United as a Novel Anti-HIV Strategy (LUNA): a Randomized Controlled Trial.
A translational proof of concept study in humans on the primary research question whether novel anti-human immunodeficiency virus (HIV) latency strategies, including a BAF inhibitor and a histone deacetylase inhibitor, result in HIV reservoir reduction in HIV patients on antiretroviral therapy.
Read the detailed description
The retrovirus HIV integrates as proviral DNA in the genome of cluster of differentiation (CD)4+ T cells. A subset form a reservoir of latently infected long-lived memory T-cells with nearly absent HIV-DNA transcription. This persistent latent HIV reservoir is the major obstacle for a cure. HIV latency is sustained by multiple host factors that restrict the viral promotor and expression of the viral genome. Latency reversing agents (LRA) can remove these restrictive components and mediate HIV latency reversal. LRA monotherapy with histone deacetylase inhibitors (HDACi) alone, including valproic acid, vorinostat, romidepsin, or panobinostat, reactivate HIV but seems insufficient to eliminate the reservoir in vivo. Our research group has identified the BAF complex as another repressive factor that maintains HIV latency. Pyrimethamine acts as an inhibitor of this BAF complex, is capable of reactivating HIV from latency at clinical tolerable concentrations, and acts synergistic with other LRA classes. This offers new opportunities for cure research. This is the first translational clinical study with BAF inhibitors and it assesses the potential synergism of 2 LRA with different modes of action on the reservoir in HIV patients.
Primary objective:
The longitudinal assessment of the effects of the BAF inhibitor pyrimethamine and of the HDACi valproic acid on the HIV reservoir in HIV patients on antiretroviral therapy.
Study design:
Open label 6 week randomized controlled intervention trial.
Study population:
Participants must be HIV infected, ≥18 years and on antiretroviral therapy with plasma HIV-RNA <50 copies/mL and CD4+ T cell count ≥200 cells/mm3 at enrollment. The HIV-RNA was ≥10.000 copies/mL before antiretroviral therapy initiation.
Intervention:
Participants are randomized to either of 4 arms and receive valproic acid, pyrimethamine, both for 2 weeks, or no intervention. Total study duration is 6 weeks and includes a 2 week treatment period and a 4 week post-treatment period.
Primary endpoint:
The change in HIV reactivation in the reservoir in vivo at treatment initiation and at the end of treatment, measured as the change in cell associated HIV-RNA. The change in reactivation is compared between the treatment arms.
Secondary endpoints:
See below.
- Conditions
- HIV-1-infection
- Being tested
- Valproic Acid, Pyrimethamine
- Keywords
- HIV, Latency reversing agents, HDAC inhibitor, BAF inhibitor, HIV reservoir, HIV cure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic AcidDrug
Also called Depakine
Valproic acid (enteric) 30mg/kg, divided over 2 doses per day, orally on day 1-14.
PyrimethamineDrug
Also called Daraprim
Pyrimethamine 200mg once daily (QD) orally on day 1 and 100mg on day 2-14.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group receives no intervention. |
| Valproic acid | Experimental | This group receives valproic acid (enteric) for 14 days. Receives: Drug: Valproic Acid |
| Pyrimethamine | Experimental | This group receives pyrimethamine for 14 days. Receives: Drug: Pyrimethamine |
| Valproic acid and Pyrimethamine | Experimental | This group receives valproic acid and pyrimethamine for 14 days. Receives: Drug: Valproic Acid; Drug: Pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell associated HIV-RNA
The change in cell associated HIV-RNA between treatment initiation (week 0) and at the end of study (week 6). The change wil be compared between the study arms.
Measured: 6 week
Secondary outcomes (20)
Tat/rev induced limiting dilution assay (TILDA)
The change in TILDA between the groups between week 2 and week 0, between week 6 and week 2, and between week 6 and week 0 The change will be compared between the study arms.
Measured: 6 week
Synergy
Potential synergism or additive effects of the administration of both drugs will be assessed by performing separate models including either both treatments or separate and subsequently investigating which model best predicts the outcome. the Bliss independence method to assess synergism will be performed. The combination therapy is considered synergistic if the difference and its 95% normal confidence interval (CI) were >0.
Measured: 6 week
Cell associated HIV-RNA
The change in cell associated HIV-RNA between and within the groups between week 2 and week 0, between week 6 and week 2, and between week 6 and week 0.
Measured: 6 week
Cell associated HIV-DNA
The change in cell associated HIV-DNA between and within the groups between week 2 and week 0, between week 6 and week 2, and between week 6 and week 0.
Measured: 6 week
Plasma HIV-RNA
The change in plasma HIV-RNA between and within the groups between week 2 and week 0, between week 6 and week 2, and between week 6 and week 0.
Measured: 6 week
Histone deacetylation
The change in the level of histone acetylation between and within the groups between week 0 and week 2, and between week 2 and week 6.
Measured: 6 week
Expression of BAF subunits
The change in the level of expression between and within the groups between week 0 and week 2, and between week 2 and week 6.
Measured: 6 week
Immunological functionality
The change of the functionality of innate immune cells, HIV specific CD4+ and CD8+ T cells and HIV specific B-cells between and within the groups between week 0 and week 2, and between week 2 and week 6.
Measured: 6 week
Immunological cytotoxicity
The change of the cytotoxicity of innate immune cells, HIV specific CD4+ and CD8+ T cells and HIV specific B-cells between and within the groups between week 0 and week 2, and between week 2 and week 6.
Measured: 6 week
Immunological phenotype
The change of the phenotype of innate immune cells, HIV specific CD4+ and CD8+ T cells and HIV specific B-cells between and within the groups between week 0 and week 2, and between week 2 and week 6.
Measured: 6 week
Reservoir biomarkers
The correlations between clinical markers, markers of the viral reservoir (HIV-DNA, HIV-RNA), frequency and functionality of immune cells, cytokines, and level of acetylation/BAF expression with the change in reservoir (cell asociated-HIVRNA and TILDA) within and between the treatment arms
Measured: 6 week
In vivo/ex vivo reservoir reactivation correlation
The correlation between ex vivo/in vitro (primary CD4 T cells, and cell line based) LRA efficacy, assessed using the size of the reservoir as measured by TILDA, HIV-DNA, HIV-RNA and level of acetylation/BAF expression after stimulation by pyrimethamine, valproic acid or both, and this will be correlated to these observed reservoir measurements outcomes in vivo at week 2 and week 6.
Measured: 6 week
Incidence of Treatment-Emergent Adverse Events
The clinical and biochemical adverse events will be assessed by the Common Toxicity Criteria.
Measured: 6 week
Plasma HIV-RNA
The proportion of subjects with plasma HIV-RNA >=20, >=50, >=200 at weeks 0, weeks 2 and week 6.
Measured: 6 week
Pharmacokinetics of dolutegravir
Plasma concentrations Cmax dolutegravir will be measured using validated methods in patients receiving these medications. The pharmacokinetic profiles of the dolutegravir will be assessed in relation to the primary endpoint and use of valproic acid.
Measured: 6 week
Pharmacokinetics of dolutegravir
Plasma concentrations Ctrough dolutegravir will be measured using validated methods in patients receiving these medications. The pharmacokinetic profiles of the dolutegravir will be assessed in relation to the primary endpoint and use of valproic acid.
Measured: 6 week
Pharmacokinetics of valproic acid
Plasma concentrations Ctrough of valproic acid will be measured using validated methods in patients receiving these medications. The total and free (nonprotein-bound) plasma concentrations of valproic acid will be measured. The pharmacokinetic profiles of the investigational medical products will be assessed in relation to the primary endpoint.
Measured: 6 week
Pharmacokinetics of valproic acid
Plasma concentrations Cmax of valproic acid will be measured using validated methods in patients receiving these medications. The total and free (nonprotein-bound) plasma concentrations of valproic acid will be measured. The pharmacokinetic profiles of the investigational medical products will be assessed in relation to the primary endpoint.
Measured: 6 week
Pharmacokinetics of pyrimethamine
Plasma concentrations Cmax of pyrimethamine will be measured using validated methods in patients receiving this medication. The pharmacokinetic profiles of the investigational medical products will be assessed in relation to the primary endpoint.
Measured: 6 week
Pharmacokinetics of pyrimethamine
Plasma concentrations Ctrough of pyrimethamine will be measured using validated methods in patients receiving this medication. The pharmacokinetic profiles of the investigational medical products will be assessed in relation to the primary endpoint.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start18 Apr 2018
- Primary completion25 Jul 2019
- Study completion1 Oct 2020
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.
- More trials run by Erasmus Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6 week study, including 2 week intervention and 4 week post-treatment period.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casper Rokx, Erasmus Medical Center
- Investigators
- Casper Rokx, MD PhD, Principal investigator, Erasmus Medical CenterTokameh Mahmoudi, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525730
- Sponsor's protocol ID
- 2017-002837-48
- Other IDs
- 2017
- Acronym
- LUNA
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No definitive decision on this yet. This will also depend on confidentiality.
Publications
Bollen PDJ, Prins HAB, Colbers A, Velthoven-Graafland K, Rijnders BJA, de Vries-Sluijs TEMS, van Nood E, Nouwen J, Bax H, de Mendonca Melo M, Verbon A, Burger DM, Rokx C. The dolutegravir/valproic acid drug-drug interaction is primarily based on protein displacement. J Antimicrob Chemother. 2021 Apr 13;76(5):1273-1276. doi: 10.1093/jac/dkab021.
PubMed 33544819
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LRAs United as a Novel Anti-HIV Strategy (LUNA): a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03525730
- Acronym / sponsor ID
- LUNA / 2017-002837-48
- Conditions
- HIV-1-infection
- Keywords
- HIV, Latency reversing agents, HDAC inhibitor, BAF inhibitor, HIV reservoir, HIV cure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 16 May 2018 (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.
A translational proof of concept study in humans on the primary research question whether novel anti-human immunodeficiency virus (HIV) latency strategies, including a BAF inhibitor and a histone deacetylase inhibitor, result in HIV reservoir reduction in HIV patients on antiretroviral therapy.
Detailed description
The retrovirus HIV integrates as proviral DNA in the genome of cluster of differentiation (CD)4+ T cells. A subset form a reservoir of latently infected long-lived memory T-cells with nearly absent HIV-DNA transcription. This persistent latent HIV reservoir is the major obstacle for a cure. HIV latency is sustained by multiple host factors that restrict the viral promotor and expression of the viral genome. Latency reversing agents (LRA) can remove these restrictive components and mediate HIV latency reversal. LRA monotherapy with histone deacetylase inhibitors (HDACi) alone, including valproic acid, vorinostat, romidepsin, or panobinostat, reactivate HIV but seems insufficient to eliminate the reservoir in vivo. Our research group has identified the BAF complex as another repressive factor that maintains HIV latency. Pyrimethamine acts as an inhibitor of this BAF complex, is capable of reactivating HIV from latency at clinical tolerable concentrations, and acts synergistic with other LRA classes. This offers new opportunities for cure research. This is the first translational clinical study with BAF inhibitors and it assesses the potential synergism of 2 LRA with different modes of action on the reservoir in HIV patients.
Primary objective:
The longitudinal assessment of the effects of the BAF inhibitor pyrimethamine and of the HDACi valproic acid on the HIV reservoir in HIV patients on antiretroviral therapy.
Study design:
Open label 6 week randomized controlled intervention trial.
Study population:
Participants must be HIV infected, ≥18 years and on antiretroviral therapy with plasma HIV-RNA <50 copies/mL and CD4+ T cell count ≥200 cells/mm3 at enrollment. The HIV-RNA was ≥10.000 copies/mL before antiretroviral therapy initiation.
Intervention:
Participants are randomized to either of 4 arms and receive valproic acid, pyrimethamine, both for 2 weeks, or no intervention. Total study duration is 6 weeks and includes a 2 week treatment period and a 4 week post-treatment period.
Primary endpoint:
The change in HIV reactivation in the reservoir in vivo at treatment initiation and at the end of treatment, measured as the change in cell associated HIV-RNA. The change in reactivation is compared between the treatment arms.
Secondary endpoints:
See below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 6 week study, including 2 week intervention and 4 week post-treatment period.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group receives no intervention. |
| Valproic acid | Experimental | Drug: Valproic AcidThis group receives valproic acid (enteric) for 14 days. |
| Pyrimethamine | Experimental | Drug: PyrimethamineThis group receives pyrimethamine for 14 days. |
| Valproic acid and Pyrimethamine | Experimental | Drug: Valproic Acid, Drug: PyrimethamineThis group receives valproic acid and pyrimethamine for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV-1 infected patients ≥18 years.
- World Health Organization (WHO) performance status 0 or 1.
- Confirmed HIV-1 infection by 4th generation ELISA, Western Blot or PCR.
- Wild type HIV infection or polymorphisms associated with at highest low-level resistance to any class of ART according to Stanford HIV drug resistance database. Transmitted mutations and acquired mutations due to virological failure associated with resistance of at highest low-level resistance are allowed.
- On cART.
Key exclusion criteria (17 listed)
- Previous virological failure, defined as either acquired resistance mutations (>low level resistance) on cART or HIV-RNA >1000 copies/mL on two consecutive measurements during cART.
- Uncontrolled hepatitis B or C co-infection. For hepatitis B: patients should be vaccinated, or on pre-exposure prophylaxis through the use of lamivudine/emtricitabine or tenofovir in their combination ART. Otherwise, standard serological testing should be available within the last 365 days for homosexual HIV positive men. For non-homosexual HIV positive persons, there should be at least one negative hepatitis B test (either by serology or PCR). For homosexual HIV positive men, a negative hepatitis C immunoglobulin G, hepatitis C (HCV) antigen, blot or HCV-RNA PCR should be available within the previous 365 days. For non-homosexual HIV positive persons, there should be at least one negative hepatitis C test (either IgG, blot or PCR) available.
- Prior exposure to any HDACi, BAFi or other known LRA.
- Prior exposure to cytotoxic myeloablative chemotherapy for hematological malignancies during cART.
- Concurrent exposure to strong interacting medication on glucuronidation.
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 |
|---|---|---|
| Valproic AcidAlso: DepakineValproic acid (enteric) 30mg/kg, divided over 2 doses per day, orally on day 1-14. | Drug | Valproic acid, Valproic acid and Pyrimethamine |
| PyrimethamineAlso: DaraprimPyrimethamine 200mg once daily (QD) orally on day 1 and 100mg on day 2-14. | Drug | Pyrimethamine, Valproic acid and Pyrimethamine |
Primary outcome
Cell associated HIV-RNA
Time frame: 6 week
The change in cell associated HIV-RNA between treatment initiation (week 0) and at the end of study (week 6). The change wil be compared between the study arms.
20 secondary outcomes
Tat/rev induced limiting dilution assay (TILDA)
Time frame: 6 week
Synergy
Time frame: 6 week
Cell associated HIV-RNA
Time frame: 6 week
Cell associated HIV-DNA
Time frame: 6 week
Plasma HIV-RNA
Time frame: 6 week
Histone deacetylation
Time frame: 6 week
Expression of BAF subunits
Time frame: 6 week
Immunological functionality
Time frame: 6 week
Immunological cytotoxicity
Time frame: 6 week
Immunological phenotype
Time frame: 6 week
Reservoir biomarkers
Time frame: 6 week
In vivo/ex vivo reservoir reactivation correlation
Time frame: 6 week
Incidence of Treatment-Emergent Adverse Events
Time frame: 6 week
Plasma HIV-RNA
Time frame: 6 week
Pharmacokinetics of dolutegravir
Time frame: 6 week
Pharmacokinetics of dolutegravir
Time frame: 6 week
Pharmacokinetics of valproic acid
Time frame: 6 week
Pharmacokinetics of valproic acid
Time frame: 6 week
Pharmacokinetics of pyrimethamine
Time frame: 6 week
Pharmacokinetics of pyrimethamine
Time frame: 6 week
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 29 Apr 2021.
- Derived from this study: PubMed 33544819Bollen PDJ, Prins HAB, Colbers A, Velthoven-Graafland K, Rijnders BJA, de Vries-Sluijs TEMS, van Nood E, Nouwen J, Bax H, de Mendonca Melo M, Verbon A, Burger DM, Rokx C. The dolutegravir/valproic acid drug-drug interaction is primarily based on protein displacement. J Antimicrob Chemother. 2021 Apr 13;76(5):1273-1276. doi: 10.1093/jac/dkab021.
- Individual participant dataSharing planned: Undecided. No definitive decision on this yet. This will also depend on confidentiality.
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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.
Casper Rokx, MD PhD principal investigator
Erasmus Medical Center
Tokameh Mahmoudi, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Valproic Acid and Pyrimethamine in people with HIV-1-infection, run by Erasmus Medical Center at 1 site in Netherlands.
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 17 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 29 Apr 2021. 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 Netherlands. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Cell associated HIV-RNA (time frame: 6 week). 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 NCT03525730, 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 29 Apr 2021.