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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Abbott | INDUSTRY |
| amfAR, The Foundation for AIDS Research | OTHER |
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The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir.
The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks.
The primary endpoint is virological: a comparison of virological suppression in plasma < 200 copies/mL between the randomized arms after 48 weeks.
Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.
In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e., non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3N(t)RTIs.
Eligible patients will be randomised to one of two arms:
I. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs
II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily
The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA < 200 copies/mL 48 weeks after randomisation.
Secondary objectives include virological, immunological, safety and antiretroviral therapy endpoints.
Exploratory endpoints include clinical, metabolic, drug resistance, medication adherence and quality of life endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ritonavir-boosted lopinavir and 2N(t)RTI | Active Comparator | This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines. |
|
| Ritonavir-boosted lopinavir and raltegravir | Experimental | This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| raltegravir | Drug | 400 mg raltegravir tablet taken every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization | 48 weeks following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population | The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment | 48 weeks |
| Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The following laboratory variables:
Pregnant or nursing mothers
Participants with active viral hepatitis B infection defined by the presence in serum of hepatitis B surface antigen
Use of immunomodulators within 30 days prior to screening
Use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John's wort)
Intercurrent illness requiring hospitalization
Active opportunistic disease not under adequate control in the opinion of the site Principal Investigator
Participants with current alcohol or illicit substance abuse that in the opinion of the site Principal Investigator might adversely affect participation in the study
Participants deemed by the site Principal Investigator unlikely to be able to remain in follow-up for the protocol-defined period
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| Name | Affiliation | Role |
|---|---|---|
| David A Cooper, MD | Kirby Institute | Study Chair |
| Brian Gazzard, MD | St. Stephen's Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Interzonal General de Agudos, Oscar Alende | Buenos Aires | Mar Del Plata Provincia | 1900 | Argentina | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33399309 | Derived | Henry RT, Jiamsakul A, Law M, Losso M, Kamarulzaman A, Phanuphak P, Kumarasamy N, Foulkes S, Mohapi L, Nwizu C, Wood R, Kelleher A, Polizzotto M; SECOND-LINE Study Group. Factors Associated With and Characteristic of HIV/Tuberculosis Co-Infection: A Retrospective Analysis of SECOND-LINE Clinical Trial Participants. J Acquir Immune Defic Syndr. 2021 May 1;87(1):720-729. doi: 10.1097/QAI.0000000000002619. | |
| 25723472 |
Not provided
Not provided
558 participants were enrolled in the study. 14 were excluded because of unverifiable data at one site and 3 dropped out before analysis, never received study treatment
Recruitment took place from Mar-2010 till Sept-2011 at 37 sites in Argentina, Australia, Chile, UK, France, Hong Kong, India, Israel, Malaysia, Mexico, Peru, Nigeria, Singapore, South Africa, and Thailand. The sites had to be clinical facilities with a cohort of suitable patients and able to do protocol-mandated procedures.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ritonavir-boosted Lopinavir and 2N(t)RTI | This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines. |
| FG001 | Ritonavir-boosted Lopinavir and Raltegravir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 5, 2009 |
Not provided
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| 2N(t)RTI | Drug | 2N(t)RTIs as prescribed |
|
|
| Ritonavir-boosted lopinavir | Drug | 2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours |
|
|
The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures: i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy |
| 48 weeks |
| Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL | The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment | 48 weeks |
| Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL | The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment | 48 weeks |
| CAICI |
| Buenos Aires |
| Rosario Provincia de Sante Fe |
| 2000 |
| Argentina |
| Hospital General de Agudos 'Teodoro Alvarez' | Buenos Aires | 1406 | Argentina |
| FUNCEI | Buenos Aires | Argentina |
| Hospital de Infecciosas FJ Muniz | Buenos Aires | Argentina |
| Hospital Italiano | Buenos Aires | Argentina |
| Hospital J.M. Ramos Mejia | Buenos Aires | Argentina |
| Hospital Prof. Alejandro Posadas | Buenos Aires | Argentina |
| Hospital Rawson | Córdoba | Argentina |
| Hospital Central | Mendoza | 5500 | Argentina |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Albion Street Centre | Sydney | New South Wales | 2010 | Australia |
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Centre Clinic | Melbourne | Victoria | 3182 | Australia |
| Hospital de la Universidad Catolica Pontificia | Santiago | Chile |
| Hospital San Borja-Arriaran | Santiago | Chile |
| Hopital Saint-Louis | Paris | France |
| Medical Group Practice | Berlin | Germany |
| J W Goethe Universitat | Frankfurt | Germany |
| Queen Elizabeth Hospital | Hong Kong | Kowloon | Hong Kong |
| Institute of Infectious Diseases | Pune | Pune | India |
| YRG Care | Chennai | India |
| Mater Misericordiae-Dublin | Dublin | Ireland |
| Hospital Pelau Pinang | Kuala Lumpur | Malaysia |
| Hospital Sungai Buloh | Kuala Lumpur | Malaysia |
| University of Malaysia | Kuala Lumpur | Malaysia |
| Hospital General de Guadalajara | Guadalajara | Mexico |
| Hospital General de Leon | León | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion "Salvado Zubiran" | Mexico City | Mexico |
| Auckland Hospital | Grafton | Auckland | 1 | New Zealand |
| Evangel Hospital (ECWA) | Jos | Plateau State | Nigeria |
| Jos University Teaching Hospital (JUTH) | Jos | Plateau State | Nigeria |
| Plateau State Specialist Hospital | Jos | Plateau State | Nigeria |
| Hospital Almenara | Lima | Peru |
| IMPACTA/Hospital Dos de Mayo | Lima | Peru |
| Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia | Lima | Peru |
| Via Libre | Lima | Peru |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Josha Research | Bloemfontein | South Africa |
| Desmond Tutu HIV Foundation | Cape Town | South Africa |
| Chris Hani Baragwanath Hospital | Soweto | South Africa |
| National Taiwan University Hospital | Taipei | Taiwan |
| Chelsea and Westminster Hospital | Fulham | London | SW10 9NH | United Kingdom |
| Derived |
| Amin J, Boyd MA, Kumarasamy N, Moore CL, Losso MH, Nwizu CA, Mohapi L, Kerr SJ, Sohn AH, Teppler H, Renjifo B, Molina JM, Emery S, Cooper DA. Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: a randomised open label study for the treatment of HIV-1 infection. PLoS One. 2015 Feb 27;10(2):e0118228. doi: 10.1371/journal.pone.0118228. eCollection 2015. |
| 24204757 | Derived | Martin A, Moore CL, Mallon PW, Hoy JF, Emery S, Belloso WH, Phanuphak P, Ferret S, Cooper DA, Boyd MA; Second-Line Study Team. HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy. PLoS One. 2013 Oct 30;8(10):e77138. doi: 10.1371/journal.pone.0077138. eCollection 2013. |
| 23769235 | Derived | SECOND-LINE Study Group; Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, Mohapi L, Martin A, Kerr S, Sohn AH, Teppler H, Van de Steen O, Molina JM, Emery S, Cooper DA. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet. 2013 Jun 15;381(9883):2091-9. doi: 10.1016/S0140-6736(13)61164-2. |
This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ritonavir-boosted Lopinavir and 2N(t)RTI | Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI |
| BG001 | Ritonavir-boosted Lopinavir and Raltegravir | Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization | modified intention-to-treat | Posted | Number | participants | 48 weeks following randomization |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population | The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment | Per protocol | Posted | Number | participants | 48 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure | The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures: i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy | Non-completer classes as failure | Posted | Number | participants | 48 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL | The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment | Baseline viral load >100,000 copies per mL | Posted | Number | participants | 48 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL | The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment | Baseline viral load <=100,000 copies per mL | Posted | Number | participants | 48 weeks |
|
|
96 weeks
AEs reported by investigators
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 | Ritonavir-boosted Lopinavir and 2N(t)RTI | This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines. | 23 | 271 | 243 | 271 | ||
| EG001 | Ritonavir-boosted Lopinavir and Raltegravir | This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable. | 24 | 270 | 232 | 270 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal Pain- death | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute Asthma Attack | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asymptomatic neuro-syphillis | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| CIN II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| CMV Retinitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Car accident - resulted in death | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Contusions resulting in hospitalisations | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cervical cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Convulsions | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cryptococcal meningitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cryptococcal disseminated | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Death - unknown, possible due to recurrent anaemia, HIV disease | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Death, cause unknown | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Death, probably due to myocardial infarction | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Delirium, secondary alcohol withdrawal | Social circumstances | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dysentery | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Extrapulmonary TB - resulted in death | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fracture of right ankle | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gangrenous bowel | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Giardiasis and nocardiasis resulting in death | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| HSV meningitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| herpez zoster | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Varizella zoster infection and MSSA cervical lymphadenitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fever and anaemia hospitalization | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Haematoma inside lower colon | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin graft detachment | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| hyponatremia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| kaposi sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lung abscess resulted in death | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| meningitis | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Plasmodiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Probable righ ovarian carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Genital bleeding | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyelonephritis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal failure resulted in death | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Right middle lobe pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin ulcers superinfected | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the anal canal - resulted in death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Stroke | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Supra Condylar fracture of right femur | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| TB meningitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tension Headache | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Varizella zoster | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Viral infection (presumptive) | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute renal impairment | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Crytococcal meningitis and giardiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea for over consumption of alcohol | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hemoptysis, resulted in death | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Right side pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bloody diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infective diarrhoea | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| miliary tuberculosis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Perianal HSV ulcer | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| probable PCP and presumptive mycobacterium TB | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Salmonella and PCP | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic conditions | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaemias nonhaemolytic and marrow depression | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Appetite and general nutritional disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bacterial infectious disorders | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Body temperature conditions | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bone, calcium, magnesium and phosphorus metabolism disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Decreased and nonspecific blood pressure disorders and shock | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dental and gingival conditions | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Epidermal and dermal conditions | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Female reproductive tract infections and inflammations | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fungal infectious disorders | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal inflammatory conditions | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal motility and defaecation conditions | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal signs and symptoms | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| General system disorders NEC | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headaches | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatic and hepatobiliary disorders | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infections - pathogen class unspecified | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injuries NEC | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Joint disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lipid metabolism disorders | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Menstrual cycle and uterine bleeding disorders | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Muscle disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders NEC | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neurological disorders NEC | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ocular infections, irritations and inflammations | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oral soft tissue conditions | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pregnancy, labour, delivery and postpartum conditions | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Protozoal infectious disorders | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal disorders (excl nephropathies) | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Reproductive tract disorders NEC | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory disorders NEC | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin appendage conditions | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sleep disorders and disturbances | General disorders and administration site conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular haemorrhagic disorders | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular hypertensive disorders | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Viral infectious disorders | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vulvovaginal disorders (excl infections and inflammations) | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
There is a Clinical Trial Agreement signed with each PI detailing the publication policy and disclosure of study's information, in summary:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Sean Emery | The Kirby Institute | +61293850900 | semery@kirby.unsw.edu.au |
| Jun 23, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D009705 | Nucleosides |
| D009711 | Nucleotides |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
|
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| Southeast Asia |
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| Europe |
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| Australia |
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| South America |
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