Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002724-83 | EudraCT Number |
Not provided
Not provided
Interim analysis did not show sufficient immunogenicity of IMP compared to placebo
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut d'Investigacions Biomèdiques August Pi i Sunyer | OTHER |
| IrsiCaixa | OTHER |
| Institute of Tropical Medicine, Belgium | OTHER |
| Vrije Universiteit Brussel |
Not provided
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iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients based on in vivo modification of DCs. It consists of HIVACAT-TriMix: mRNA encoding a mixture of APC activation molecules (CD40L, a constitutively active variant of TLR4 and CD70) and the HIV target antigens contained in HIVACAT to be administered through the intranodal route. iHIVARNA-01 aims to achieve the 'functional cure' of HIV infection, i.e. controlling viral replication in the absence of anti-retroviral therapy.
Objective: To evaluate the safety and immunogenicity of iHIVARNA-01 as a new therapeutic vaccine in HIV infected patients.
Study design and duration: Phase IIa, multicentre double-blind placebo controlled intervention study. Each patient will be followed for 30 weeks. The study duration will be 38 weeks from inclusion of the first patient.
Sites: Erasmus MC, Rotterdam The Netherlands (sponsor), Hospital ClÃnic de Barcelona and Institut de Recerca de la Sida - Caixa, Barcelona, Spain, Instituut voor Tropische Geneeskunde Antwerp, Belgium and Vrije Universiteit Brussel/UZ Brussel, Belgium
Study population: Chronically HIV-1- infected patients under stable cART with plasma viral load (pVL) ≤ 50 copies/ml and stable CD4+ T-cell counts ≥ 450/μl, aged 18 years or above.
Sample size: after recruitment and screening, 70 patients will be included and randomized to one of the study-arms.
Intervention: One group (n=40) receives the HIVACAT-TriMix (300 microgram TriMix + 900 microgram HIVACAT) vaccine intranodally on three occasions with a two-week interval. One control group (n=15) receives TriMix only (300 microgram TriMix) and one group (n=15) receives saline intranodally on three occasions with a two-week interval. Two weeks after the last vaccination cART treatment will be interrupted. If plasma virus is detectable, cART will be re-initiated twelve weeks after treatment interruption. cART can always be re-initiated for medical reasons, as judged by the clinical investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iHIVARNA-01 | Experimental | Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval |
|
| TriMix | Active Comparator | Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval |
|
| Placebo | Placebo Comparator | Water for injection 3 vaccinations, two weeks interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iHIVARNA-01 | Biological | Therapeutic vaccination, followed by treatment interruption |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
Any event attributable to vaccination leading to discontinuation of the immunisation regimen. | week 6 |
| Immunogenicity as Measured by Elispot | Change from baseline immunogenicity as measured by ELISPOT at week 6 and 18, i.e. two weeks and 14 weeks after the last immunization compared to both control groups | week 6 and week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity as Measured by Intracellular Cytokine Staining (ICS) | HIV-specific CD4+ and CD8+ T cell responses after immunization by the number of poly-functional T cells as determined by intracellular cytokine staining, (ICS). | week 10, 18 and 30 |
| Time to Viral Rebound |
Not provided
Inclusion Criteria:
≥ 18 years of age;
Voluntarily signed informed consent;
Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
Nadir CD4+ ≥ 350 cells/μl (up to 2 occasional determinations ≤ 350 cells/μl are allowed);
Current CD4+ cell count ≥ 450 cells/μl;
HIV-RNA below 50 copies/mL in the last 6 months prior to randomization, during at least two measurements (occasional so called 'blips' ≤ 500 copies/mL are permitted);
If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (including PrEP).
For heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination. -
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Rob A Gruters, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Tropical Medicine | Antwerp | Belgium | ||||
| UZ Brussel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31208472 | Derived | de Jong W, Aerts J, Allard S, Brander C, Buyze J, Florence E, van Gorp E, Vanham G, Leal L, Mothe B, Thielemans K, Plana M, Garcia F, Gruters R; iHIVARNA consortium. iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy. Trials. 2019 Jun 17;20(1):361. doi: 10.1186/s13063-019-3409-1. |
| Label | URL |
|---|---|
| Description phase 1 clinical trial with iHIVARNA-01 | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | iHIVARNA-01 | Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption TriMix: Therapeutic vaccination, followed by treatment interruption |
| FG001 | TriMix | Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval TriMix: Therapeutic vaccination, followed by treatment interruption |
| FG002 | Placebo | Water for injection 3 vaccinations, two weeks interval Placebo: Therapeutic vaccination, followed by treatment interruption |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccination Period |
| |||||||||||||
| Analytical Treatment Interruption |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | iHIVARNA-01 | Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption TriMix: Therapeutic vaccination, followed by treatment interruption |
| BG001 | TriMix |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
Any event attributable to vaccination leading to discontinuation of the immunisation regimen. | Posted | Count of Participants | Participants | week 6 |
|
30 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iHIVARNA-01 | Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval iHIVARNA-01: Therapeutic vaccination, followed by treatment interruption TriMix: Therapeutic vaccination, followed by treatment interruption |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotensions | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
Limited number of subjects for statistical analysis due to early termination. There was an error in the study product, see https://insights.ovid.com/pubmed?pmid=31490219
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr R.A. Gruters | Erasmus MC | +31 10 7032100 | r.gruters@erasmusmc.nl |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2017 | Oct 4, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D016180 | Lentivirus Infections |
| D014777 | Virus Diseases |
| D012749 | Sexually Transmitted Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| C045257 | trimix |
Not provided
Not provided
Not provided
| OTHER |
| Synapse bv | INDUSTRY |
| Asphalion | UNKNOWN |
| eTheRNA immunotherapies | INDUSTRY |
| CR2O | UNKNOWN |
| Hospital Clinic of Barcelona | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
Not provided
Not provided
Not provided
Not provided
| TriMix | Biological | Therapeutic vaccination, followed by treatment interruption |
|
| Placebo | Biological | Therapeutic vaccination, followed by treatment interruption |
|
time until viral rebound (defined as two consecutive measurements of plasma viral load > 1000 copies/mL separated by at least 15 days) after discontinuation at week 6. |
| week 6-18 |
| Change in Plasma Viral Load | difference in log10 copies/ml plasma viral load in vivo after analytical treatment interruption (ATI, week 6-restart ART), compared to placebo WFI | week 6-18 |
| Functional Cure | proportion of patients with viral load below detectable level of 50 copies/mL in plasma after ATI, week 18 | week 18 |
| Primary Immune Response Against Vaccine | Change in frequency of at least 0.7log10 HIV-specific T-cell responses between baseline and week 6 | from baseline to week 6 |
| CD8 T Cell Mediated Viral Suppression | The capacity of CD8 T cells to suppress virus production in HIV infected autologous CD4 T cells, after vaccination. For this purpose PBMC are isolated and separated in CD8 and CD4 T cells. CD4 cells are infected with HIV. Thereafter CD4 cells are co-cultured with pre-stimulated CD8 cells and the capacity to suppress virus production at different effector to target (E:T) ratios is measured, by the change of p24 Gag production. Pannus et al AIDS 2019, PMID: 30702513 | week 4 |
| Proviral DNA Reservoir | effect on reservoir as measured by changes in the proviral DNA copy numbers per million cells during and after immunization | day 0-90 (week 4, week 4 + 1 day and week 5 and week 6) and day 90-130 (week 18) and day >130 (week 30) |
| Viral Immune Escape | viral immune escape: change in % mutated epitopes from pre-cART to post-ATI | week 18 |
| Transcriptomics | host protein mRNA expression profiles in whole blood | week 6 and 18 |
| Cell-associated RNA Viral Reservoir | effect on reservoir as measured by changes in the intracellular viral RNA copy numbers per million cells during and after immunization | day 0-30 (week 4, week 4 + 1 day and week 5) and day 30-80 (week 6), 80-150 days (week 18) and >150 days (week 30) |
| Brussels |
| Belgium |
| Erasmus MC | Rotterdam | Netherlands |
| Hospital Universitari Germans Trias i Pujol | Badalona | Spain |
| Hospital Clinic | Barcelona | Spain |
| NOT COMPLETED |
|
|
Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval TriMix: Therapeutic vaccination, followed by treatment interruption |
| BG002 | Placebo | Water for injection 3 vaccinations, two weeks interval Placebo: Therapeutic vaccination, followed by treatment interruption |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4 T cell counts | Median | Inter-Quartile Range | cells/microliter |
|
| TriMix |
Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval TriMix: Therapeutic vaccination, followed by treatment interruption |
| OG002 | Placebo | Water for injection 3 vaccinations, two weeks interval Placebo: Therapeutic vaccination, followed by treatment interruption |
|
|
| Primary | Immunogenicity as Measured by Elispot | Change from baseline immunogenicity as measured by ELISPOT at week 6 and 18, i.e. two weeks and 14 weeks after the last immunization compared to both control groups | Posted | Mean | 95% Confidence Interval | delta log difference spot forming units | week 6 and week 18 |
|
|
|
|
| Secondary | Immunogenicity as Measured by Intracellular Cytokine Staining (ICS) | HIV-specific CD4+ and CD8+ T cell responses after immunization by the number of poly-functional T cells as determined by intracellular cytokine staining, (ICS). | The data were not collected. In the protocol it was pre-specified, that ICS would not be done if Elispot results did not show immunogenicity of the study product. This analysis was not performed, because the results from the Elispot assay at the same time points showed no increase in the number of spot-forming units, also see primary outcome two. | Posted | week 10, 18 and 30 |
|
|
| Secondary | Time to Viral Rebound | time until viral rebound (defined as two consecutive measurements of plasma viral load > 1000 copies/mL separated by at least 15 days) after discontinuation at week 6. | One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial. | Posted | Median | 95% Confidence Interval | days | week 6-18 |
|
|
|
| Secondary | Change in Plasma Viral Load | difference in log10 copies/ml plasma viral load in vivo after analytical treatment interruption (ATI, week 6-restart ART), compared to placebo WFI | One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial. | Posted | Geometric Mean | 95% Confidence Interval | log10 copies/ml | week 6-18 |
|
|
|
| Secondary | Functional Cure | proportion of patients with viral load below detectable level of 50 copies/mL in plasma after ATI, week 18 | One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial. | Posted | Count of Participants | Participants | No | week 18 |
|
|
|
| Secondary | Primary Immune Response Against Vaccine | Change in frequency of at least 0.7log10 HIV-specific T-cell responses between baseline and week 6 | Posted | Mean | 95% Confidence Interval | delta log spot forming units | from baseline to week 6 |
|
|
|
| Secondary | CD8 T Cell Mediated Viral Suppression | The capacity of CD8 T cells to suppress virus production in HIV infected autologous CD4 T cells, after vaccination. For this purpose PBMC are isolated and separated in CD8 and CD4 T cells. CD4 cells are infected with HIV. Thereafter CD4 cells are co-cultured with pre-stimulated CD8 cells and the capacity to suppress virus production at different effector to target (E:T) ratios is measured, by the change of p24 Gag production. Pannus et al AIDS 2019, PMID: 30702513 | Posted | Mean | 95% Confidence Interval | log(pg/ml) | week 4 |
|
|
|
| Secondary | Proviral DNA Reservoir | effect on reservoir as measured by changes in the proviral DNA copy numbers per million cells during and after immunization | Posted | Mean | 95% Confidence Interval | delta log copies DNA /10E6 cel | day 0-90 (week 4, week 4 + 1 day and week 5 and week 6) and day 90-130 (week 18) and day >130 (week 30) |
|
|
|
| Secondary | Viral Immune Escape | viral immune escape: change in % mutated epitopes from pre-cART to post-ATI | data were not collected | Posted | week 18 |
|
|
| Secondary | Transcriptomics | host protein mRNA expression profiles in whole blood | data were not collected | Posted | week 6 and 18 |
|
|
| Secondary | Cell-associated RNA Viral Reservoir | effect on reservoir as measured by changes in the intracellular viral RNA copy numbers per million cells during and after immunization | Posted | Mean | 95% Confidence Interval | delta log copies RNA/ml | day 0-30 (week 4, week 4 + 1 day and week 5) and day 30-80 (week 6), 80-150 days (week 18) and >150 days (week 30) |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| 16 |
| 16 |
| EG001 | TriMix | Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval TriMix: Therapeutic vaccination, followed by treatment interruption | 0 | 9 | 0 | 9 | 9 | 9 |
| EG002 | Placebo | Water for injection 3 vaccinations, two weeks interval Placebo: Therapeutic vaccination, followed by treatment interruption | 0 | 8 | 1 | 8 | 8 | 8 |
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cyst | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| influenza-like illness | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Injection site puritis | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Tenderness | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Urethritis | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Burn-out syndrome | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Mental disoreder | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| wrist fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood creatine-phospho kinase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Entercolitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Erythemia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Althragia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Muscles spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Eyelid infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Furunkel | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastro enteritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Hepatitis viral | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Sexually transmitted disease | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
Not provided
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| proviral DNA 90-130 days |
|
| proviral DNA >130 days |
|
|
| caRNA 80-150 days |
|
| caRNA >150 days |
|