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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Janssen Pharmaceutica | INDUSTRY |
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Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant.
This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) |
|
| Arm B | Active Comparator | abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) |
|
| Arm C | Active Comparator | emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) | Drug | Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Plasma HIV RNA < 50 Copies/mL | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With WHO Stage 3 and 4 HIV Related Events | patients having a diagnosis of HIV related event classified as stage 3 or 4 | between baseline and 48 weeks |
| Patients With Plasma HIV RNA < 200 Copies/ml |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Sinata Koulla Shiro, PhD | Infectious diseases department, Central Hospital, Yaounde, Cameroon | Principal Investigator |
| Papa Salif Sow, PhD | Infectious Diseases Department, Fann Hospital, Dakar, Senegal | Principal Investigator |
| Adrien Sawadogo, MD | Day Hospital, CHU Sanou Souro, Bobo Dioulasso, Burkina Faso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Day Hospital, CHU Sanou Souro | Bobo-Dioulasso | Burkina Faso | ||||
| Day Hospital, Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31273686 | Derived | Boyer S, Nishimwe ML, Sagaon-Teyssier L, March L, Koulla-Shiro S, Bousmah MQ, Toby R, Mpoudi-Etame MP, Ngom Gueye NF, Sawadogo A, Kouanfack C, Ciaffi L, Spire B, Delaporte E; 2-Lady Group. Cost-Effectiveness of Three Alternative Boosted Protease Inhibitor-Based Second-Line Regimens in HIV-Infected Patients in West and Central Africa. Pharmacoecon Open. 2020 Mar;4(1):45-60. doi: 10.1007/s41669-019-0157-9. |
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584 patients assessed for eligibility, 130 excluded primary (13.9%) because control viral load decreased below 1000 copies/mL after adherence support.
Recruitment in three study sites (Yaoundé, Dakar and Bobo Dioulasso) in HIV day care clinics from January 2010 to September 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) | Drug | Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening |
|
| emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation) | Drug | Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food |
|
number of patients with plasma HIV RNA below 200 copies/ml
| 48 weeks |
| Gain in CD4 Cells Between Baseline and W48 | median gain in circulating CD4 cells between baseline and W48 | between baseline and 48 weeks |
| Number of Patients Discontinuing Study Treatment | number of patients discounting treatment because of adverse events | between baseline and W48 |
| Tolerance: Gastrointestinal Complains | Gastrointestinal complaints (grade 1 to 4) between baseline and W48. | between baseline and 48 weeks |
| Tolerance: Neuropathies (Grade 1 to 4) | any symptom of peripheral neuropathy | between baseline and W48 |
| Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate) | evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value | between baseline and W48 |
| Adherence | number of patients in different categories of adherence as measured by questionnaire | between baseline and W48 |
| Number of Patients With Resistance Mutations | number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml) | between W12 and W48 |
| Development of Metabolic Syndrome | number of patients developing metabolic syndrome over a period of 48 weeks | from baseline to week 48 |
| Number of Patients With HIV Plasma Viral Load < 50 Copies/ml | Snapshot of patients with HIV viral load less then 50 copies/ml at week 24 | Week 24 |
| Number of Patients With HIV Plasma Viral Load < 200 Copies/ml | number of patients having a plasma viral load below 200 copies/ml at week 24 | Week 24 |
| Yaoundé |
| Cameroon |
| Clinical Research and Training Center, Fann Hospital | Dakar | Senegal |
| Arm B |
abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening |
| FG002 | Arm C | emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation) emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food |
| Analysed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening |
| BG001 | Arm B | abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening |
| BG002 | Arm C | emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation) emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food |
| BG003 | 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 | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HIV RNA Viral Load | Median | Inter-Quartile Range | log10 (copies/ml) |
| |||||||||||||||
| Resistance to the three first-line drugs | Number | participants |
| ||||||||||||||||
| CD4 cells count | Median | Inter-Quartile Range | cells/mm3 |
|
| 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 Patients With Plasma HIV RNA < 50 Copies/mL | ITT | Posted | Number | participants | 48 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With WHO Stage 3 and 4 HIV Related Events | patients having a diagnosis of HIV related event classified as stage 3 or 4 | ITT | Posted | Number | participants | between baseline and 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Plasma HIV RNA < 200 Copies/ml | number of patients with plasma HIV RNA below 200 copies/ml | ITT | Posted | Number | participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Gain in CD4 Cells Between Baseline and W48 | median gain in circulating CD4 cells between baseline and W48 | ITT with data available | Posted | Median | Inter-Quartile Range | cell/mm3 | between baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Discontinuing Study Treatment | number of patients discounting treatment because of adverse events | ITT | Posted | Number | participants | between baseline and W48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tolerance: Gastrointestinal Complains | Gastrointestinal complaints (grade 1 to 4) between baseline and W48. | ITT | Posted | Number | participants | between baseline and 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tolerance: Neuropathies (Grade 1 to 4) | any symptom of peripheral neuropathy | ITT | Posted | Number | participants | between baseline and W48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate) | evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value | ITT | Posted | Number | participants | between baseline and W48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adherence | number of patients in different categories of adherence as measured by questionnaire | patients with data available | Posted | Number | participants | between baseline and W48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Resistance Mutations | number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml) | patients who failed second line (2 HIV RNA measure above 1000 copies/ml) | Posted | Number | participants | between W12 and W48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Development of Metabolic Syndrome | number of patients developing metabolic syndrome over a period of 48 weeks | population with data available | Posted | Count of Participants | Participants | from baseline to week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With HIV Plasma Viral Load < 50 Copies/ml | Snapshot of patients with HIV viral load less then 50 copies/ml at week 24 | ITT | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With HIV Plasma Viral Load < 200 Copies/ml | number of patients having a plasma viral load below 200 copies/ml at week 24 | ITT | Posted | Count of Participants | Participants | Week 24 |
|
48 Weeks
SAE grade 3, grade 4 and hospitalisation
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 | Arm A | emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening | 13 | 152 | 131 | 152 | ||
| EG001 | Arm B | abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening | 22 | 145 | 122 | 145 | ||
| EG002 | Arm C | emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation) emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food | 19 | 154 | 118 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial injury | Injury, poisoning and procedural complications | CIM 10 | Non-systematic Assessment |
| |
| Acute posthemorrhagic anemia | Blood and lymphatic system disorders | CIM 10 | Non-systematic Assessment |
| |
| Other anaemias | Blood and lymphatic system disorders | CIM 10 | Non-systematic Assessment |
| |
| Pulmonary embolism | Cardiac disorders | CIM 10 | Non-systematic Assessment |
| |
| Unspecified diabetes mellitus | Endocrine disorders | CIM 10 | Non-systematic Assessment |
| |
| Other functional intestinal disorders | Gastrointestinal disorders | CIM 10 | Non-systematic Assessment |
| |
| Other noninfective gastroenteritis and colitis | Gastrointestinal disorders | CIM 10 | Non-systematic Assessment |
| |
| Abdominal and pelvic pain | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Abnormal findings on diagnostic imaging of lung | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Abnormal serum enzyme levels | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Abnormalities of breathing | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Cough | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Elevated blood glucose level | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Fever of other and unknown origin | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Headache | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Malaise and fatigue | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Pain in throat and chest | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Symptoms and signs concerning food and fluid intake | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Unattended death | General disorders | CIM 10 | Non-systematic Assessment |
| |
| Infectious gastroenteritis and colitis, unspecified | Infections and infestations | CIM 10 | Non-systematic Assessment |
| |
| Other septicaemia | Infections and infestations | CIM 10 | Non-systematic Assessment |
| |
| Respiratory tuberculosis, bacteriologically and histologically confirmed | Infections and infestations | CIM 10 | Non-systematic Assessment |
| |
| Respiratory tuberculosis, not confirmed bacteriologically or histologically | Infections and infestations | CIM 10 | Non-systematic Assessment |
| |
| Tuberculosis of other organs | Infections and infestations | CIM 10 | Non-systematic Assessment |
| |
| Unspecified malaria | Infections and infestations | CIM 10 | Non-systematic Assessment |
| |
| Medical observation and evaluation for suspected diseases and conditions | Injury, poisoning and procedural complications | CIM 10 | Non-systematic Assessment |
| |
| Unspecified severe protein- calorie malnutrition | Metabolism and nutrition disorders | CIM 10 | Non-systematic Assessment |
| |
| Volume depletion | Metabolism and nutrition disorders | CIM 10 | Non-systematic Assessment |
| |
| Malignant neoplasm of liver and intrahepatic bile ducts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CIM 10 | Non-systematic Assessment |
| |
| Other abnormal products of conception | Pregnancy, puerperium and perinatal conditions | CIM 10 | Non-systematic Assessment |
| |
| Spontaneous abortion | Pregnancy, puerperium and perinatal conditions | CIM 10 | Non-systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | CIM 10 | Non-systematic Assessment |
| |
| Acute tubulo-interstitial nephritis | Renal and urinary disorders | CIM 10 | Non-systematic Assessment |
| |
| Other disorders of urinary system | Renal and urinary disorders | CIM 10 | Non-systematic Assessment |
| |
| Unspecified renal failure | Renal and urinary disorders | CIM 10 | Non-systematic Assessment |
| |
| Excessive, frequent and irregular menstruation | Reproductive system and breast disorders | CIM 10 | Non-systematic Assessment |
| |
| Salpingitis and oophoritis | Reproductive system and breast disorders | CIM 10 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | CIM 10 | Non-systematic Assessment |
| |
| Bacterial pneumonia, not elsewhere classified | Respiratory, thoracic and mediastinal disorders | CIM 10 | Non-systematic Assessment |
| |
| Pneumonia in diseases classified elsewhere | Respiratory, thoracic and mediastinal disorders | CIM 10 | Non-systematic Assessment |
| |
| Pneumonia, organism unspecified | Respiratory, thoracic and mediastinal disorders | CIM 10 | Non-systematic Assessment |
| |
| Respiratory failure, not elsewhere classified | Respiratory, thoracic and mediastinal disorders | CIM 10 | Non-systematic Assessment |
| |
| Cutaneous abscess, furuncle and carbuncle | Skin and subcutaneous tissue disorders | CIM 10 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | CIM 10 | Non-systematic Assessment |
| |
| Lichen simplex chronicus and prurigo | Skin and subcutaneous tissue disorders | CIM 10 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CIM 10 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | CIM10 | Non-systematic Assessment |
| |
| Other functional intestinal disorders | Gastrointestinal disorders | CIM10 | Non-systematic Assessment |
| |
| Other noninfective gastroenteritis and colitis | Gastrointestinal disorders | CIM10 | Non-systematic Assessment |
| |
| Abdominal and pelvic pain | General disorders | CIM10 | Non-systematic Assessment |
| |
| Cough | General disorders | CIM10 | Non-systematic Assessment |
| |
| Fever of other and unknown origin | General disorders | CIM10 | Non-systematic Assessment |
| |
| Headache | General disorders | CIM10 | Non-systematic Assessment |
| |
| Malaise and fatigue | General disorders | CIM10 | Non-systematic Assessment |
| |
| Nausea and vomiting | General disorders | CIM10 | Non-systematic Assessment |
| |
| Pain, not elsewhere classified | General disorders | CIM10 | Non-systematic Assessment |
| |
| Symptoms and signs concerning food and fluid intake | General disorders | CIM10 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | CIM10 | Non-systematic Assessment |
| |
| Infectious gastroenteritis and colitis, unspecified | Infections and infestations | CIM10 | Non-systematic Assessment |
| |
| Unspecified malaria | Infections and infestations | CIM10 | Non-systematic Assessment |
| |
| Contraceptive management | Injury, poisoning and procedural complications | CIM10 | Non-systematic Assessment |
| |
| Pregnancy examination and test | Injury, poisoning and procedural complications | CIM10 | Non-systematic Assessment |
| |
| Dorsalgia | Musculoskeletal and connective tissue disorders | CIM10 | Non-systematic Assessment |
| |
| Other joint disorders, not elsewhere classified | Musculoskeletal and connective tissue disorders | CIM10 | Non-systematic Assessment |
| |
| Other polyneuropathies | Nervous system disorders | CIM10 | Non-systematic Assessment |
| |
| Other inflammation of vagina and vulva | Reproductive system and breast disorders | CIM10 | Non-systematic Assessment |
| |
| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | CIM10 | Non-systematic Assessment |
| |
| Acute nasopharyngitis [common cold] | Respiratory, thoracic and mediastinal disorders | CIM10 | Non-systematic Assessment |
| |
| Influenza, virus not identified | Respiratory, thoracic and mediastinal disorders | CIM10 | Non-systematic Assessment |
| |
| Cutaneous abscess, furuncle and carbuncle | Skin and subcutaneous tissue disorders | CIM10 | Non-systematic Assessment |
| |
| Lichen simplex chronicus and prurigo | Skin and subcutaneous tissue disorders | CIM10 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CIM10 | Non-systematic Assessment |
|
Limitations: open label design, random imbalance at baseline. Non-inferiority not shown, results influenced by the hypothesis of 80% viral success (50 copies/mL), not reached (69% in the control group). Therefore, the study power was reduced (80%).
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Laura Ciaffi | UMI 233 IRD Montpellier | 00237 694926786 | lauraciaffi2002@yahoo.fr |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| D061466 | Lopinavir |
| C106538 | abacavir |
| D016049 | Didanosine |
| D019438 | Ritonavir |
| D000069454 | Darunavir |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D015224 | Dideoxynucleosides |
| D012263 | Ribonucleosides |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D005663 | Furans |
Not provided
Not provided
| Male |
|
| Burkina Faso |
|
| Senegal |
|
| difference in proportions |
| 6.1 |
| 2-Sided |
| 95 |
| -4.5 |
| 16.7 |
| Yes |
| Non-Inferiority or Equivalence |
Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%. |
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