Trial Outcomes & Findings for A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen (NCT NCT00931463)
NCT ID: NCT00931463
Last Updated: 2019-09-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
558 participants
Primary outcome timeframe
48 weeks following randomization
Results posted on
2019-09-04
Participant Flow
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.
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
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
271
|
270
|
|
Overall Study
COMPLETED
|
254
|
265
|
|
Overall Study
NOT COMPLETED
|
17
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen
Baseline characteristics by cohort
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=271 Participants
Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
|
Ritonavir-boosted Lopinavir and Raltegravir
n=270 Participants
Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
38.55 years
STANDARD_DEVIATION 8.84 • n=7 Participants
|
38.78 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Region of Enrollment
Africa
|
100 participants
n=5 Participants
|
96 participants
n=7 Participants
|
196 participants
n=5 Participants
|
|
Region of Enrollment
Southeast Asia
|
116 participants
n=5 Participants
|
113 participants
n=7 Participants
|
229 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
South America
|
53 participants
n=5 Participants
|
59 participants
n=7 Participants
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeks following randomizationPopulation: modified intention-to-treat
Outcome measures
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=271 Participants
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
n=270 Participants
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.
|
|---|---|---|
|
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization
|
219 participants
|
223 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Per protocol
The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment
Outcome measures
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=249 Participants
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
n=246 Participants
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.
|
|---|---|---|
|
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population
|
211 participants
|
211 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Non-completer classes 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
Outcome measures
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=271 Participants
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
n=270 Participants
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.
|
|---|---|---|
|
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure
|
208 participants
|
210 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Baseline viral load \>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
Outcome measures
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=52 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL
|
31 participants
|
39 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Baseline viral load \<=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
Outcome measures
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=219 Participants
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
n=210 Participants
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.
|
|---|---|---|
|
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
|
188 participants
|
184 participants
|
Adverse Events
Ritonavir-boosted Lopinavir and 2N(t)RTI
Serious events: 23 serious events
Other events: 243 other events
Deaths: 0 deaths
Ritonavir-boosted Lopinavir and Raltegravir
Serious events: 24 serious events
Other events: 232 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=271 participants at risk
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
n=270 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.74%
2/270 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Abdominal Pain- death
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Respiratory, thoracic and mediastinal disorders
Acute Asthma Attack
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.74%
2/270 • 96 weeks
AEs reported by investigators
|
|
Nervous system disorders
Asymptomatic neuro-syphillis
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CIN II
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
CMV Retinitis
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Injury, poisoning and procedural complications
Car accident - resulted in death
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Injury, poisoning and procedural complications
Contusions resulting in hospitalisations
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical cancer
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
General disorders
Convulsions
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Cryptococcal meningitis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Cryptococcal disseminated
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Death - unknown, possible due to recurrent anaemia, HIV disease
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
General disorders
Death, cause unknown
|
0.74%
2/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
General disorders
Death, probably due to myocardial infarction
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Social circumstances
Delirium, secondary alcohol withdrawal
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Dysentery
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Extrapulmonary TB - resulted in death
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Injury, poisoning and procedural complications
Fracture of right ankle
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Gangrenous bowel
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Giardiasis and nocardiasis resulting in death
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
HSV meningitis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
herpez zoster
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Respiratory, thoracic and mediastinal disorders
haemothorax
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Varizella zoster infection and MSSA cervical lymphadenitis
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Fever and anaemia hospitalization
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Haematoma inside lower colon
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Surgical and medical procedures
Skin graft detachment
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
kaposi sarcoma
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Respiratory, thoracic and mediastinal disorders
Lung abscess resulted in death
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Nervous system disorders
meningitis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Plasmodiasis
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
pneumonia
|
1.1%
3/271 • 96 weeks
AEs reported by investigators
|
1.1%
3/270 • 96 weeks
AEs reported by investigators
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.8%
5/271 • 96 weeks
AEs reported by investigators
|
2.6%
7/270 • 96 weeks
AEs reported by investigators
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Probable righ ovarian carcinoma
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Reproductive system and breast disorders
Genital bleeding
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.74%
2/270 • 96 weeks
AEs reported by investigators
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Renal and urinary disorders
Renal failure resulted in death
|
0.74%
2/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Respiratory, thoracic and mediastinal disorders
Right middle lobe pneumonia
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Sepsis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Skin ulcers superinfected
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the anal canal - resulted in death
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Vascular disorders
Stroke
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Injury, poisoning and procedural complications
Supra Condylar fracture of right femur
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
TB meningitis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
General disorders
Tension Headache
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Eye disorders
Uveitis
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Varizella zoster
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Viral infection (presumptive)
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Renal and urinary disorders
Acute renal impairment
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Crytococcal meningitis and giardiasis
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Diarrhoea for over consumption of alcohol
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Hemoptysis, resulted in death
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Respiratory, thoracic and mediastinal disorders
Right side pleural effusion
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Bloody diarrhoea
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
diarrhoea
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Infective diarrhoea
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
miliary tuberculosis
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Perianal HSV ulcer
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
pneumocystis jirovecii pneumonia
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Pneumonia
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
probable PCP and presumptive mycobacterium TB
|
0.00%
0/271 • 96 weeks
AEs reported by investigators
|
0.37%
1/270 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Salmonella and PCP
|
0.37%
1/271 • 96 weeks
AEs reported by investigators
|
0.00%
0/270 • 96 weeks
AEs reported by investigators
|
Other adverse events
| Measure |
Ritonavir-boosted Lopinavir and 2N(t)RTI
n=271 participants at risk
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
n=270 participants at risk
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.
|
|---|---|---|
|
General disorders
Allergic conditions
|
4.4%
12/271 • Number of events 15 • 96 weeks
AEs reported by investigators
|
3.0%
8/270 • Number of events 8 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Anaemias nonhaemolytic and marrow depression
|
3.7%
10/271 • Number of events 21 • 96 weeks
AEs reported by investigators
|
4.1%
11/270 • Number of events 12 • 96 weeks
AEs reported by investigators
|
|
Metabolism and nutrition disorders
Appetite and general nutritional disorders
|
9.2%
25/271 • Number of events 33 • 96 weeks
AEs reported by investigators
|
4.4%
12/270 • Number of events 16 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Bacterial infectious disorders
|
3.3%
9/271 • Number of events 11 • 96 weeks
AEs reported by investigators
|
2.6%
7/270 • Number of events 7 • 96 weeks
AEs reported by investigators
|
|
General disorders
Body temperature conditions
|
9.6%
26/271 • Number of events 32 • 96 weeks
AEs reported by investigators
|
8.5%
23/270 • Number of events 26 • 96 weeks
AEs reported by investigators
|
|
Metabolism and nutrition disorders
Bone, calcium, magnesium and phosphorus metabolism disorders
|
2.6%
7/271 • Number of events 7 • 96 weeks
AEs reported by investigators
|
2.2%
6/270 • Number of events 6 • 96 weeks
AEs reported by investigators
|
|
Blood and lymphatic system disorders
Decreased and nonspecific blood pressure disorders and shock
|
4.8%
13/271 • Number of events 13 • 96 weeks
AEs reported by investigators
|
5.6%
15/270 • Number of events 17 • 96 weeks
AEs reported by investigators
|
|
General disorders
Dental and gingival conditions
|
0.74%
2/271 • Number of events 3 • 96 weeks
AEs reported by investigators
|
2.6%
7/270 • Number of events 7 • 96 weeks
AEs reported by investigators
|
|
Skin and subcutaneous tissue disorders
Epidermal and dermal conditions
|
24.4%
66/271 • Number of events 108 • 96 weeks
AEs reported by investigators
|
24.4%
66/270 • Number of events 115 • 96 weeks
AEs reported by investigators
|
|
Reproductive system and breast disorders
Female reproductive tract infections and inflammations
|
5.2%
14/271 • Number of events 18 • 96 weeks
AEs reported by investigators
|
5.6%
15/270 • Number of events 22 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Fungal infectious disorders
|
12.2%
33/271 • Number of events 39 • 96 weeks
AEs reported by investigators
|
17.4%
47/270 • Number of events 54 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Gastrointestinal inflammatory conditions
|
1.1%
3/271 • Number of events 3 • 96 weeks
AEs reported by investigators
|
3.0%
8/270 • Number of events 8 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Gastrointestinal motility and defaecation conditions
|
47.2%
128/271 • Number of events 177 • 96 weeks
AEs reported by investigators
|
37.8%
102/270 • Number of events 131 • 96 weeks
AEs reported by investigators
|
|
Gastrointestinal disorders
Gastrointestinal signs and symptoms
|
26.6%
72/271 • Number of events 145 • 96 weeks
AEs reported by investigators
|
18.9%
51/270 • Number of events 82 • 96 weeks
AEs reported by investigators
|
|
General disorders
General system disorders NEC
|
12.5%
34/271 • Number of events 47 • 96 weeks
AEs reported by investigators
|
12.2%
33/270 • Number of events 41 • 96 weeks
AEs reported by investigators
|
|
General disorders
Headaches
|
15.1%
41/271 • Number of events 52 • 96 weeks
AEs reported by investigators
|
11.1%
30/270 • Number of events 36 • 96 weeks
AEs reported by investigators
|
|
Hepatobiliary disorders
Hepatic and hepatobiliary disorders
|
0.74%
2/271 • Number of events 2 • 96 weeks
AEs reported by investigators
|
3.0%
8/270 • Number of events 8 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Infections - pathogen class unspecified
|
38.0%
103/271 • Number of events 188 • 96 weeks
AEs reported by investigators
|
45.9%
124/270 • Number of events 243 • 96 weeks
AEs reported by investigators
|
|
Injury, poisoning and procedural complications
Injuries NEC
|
3.0%
8/271 • Number of events 8 • 96 weeks
AEs reported by investigators
|
4.8%
13/270 • Number of events 13 • 96 weeks
AEs reported by investigators
|
|
Musculoskeletal and connective tissue disorders
Joint disorders
|
4.8%
13/271 • Number of events 15 • 96 weeks
AEs reported by investigators
|
8.1%
22/270 • Number of events 23 • 96 weeks
AEs reported by investigators
|
|
Endocrine disorders
Lipid metabolism disorders
|
2.2%
6/271 • Number of events 6 • 96 weeks
AEs reported by investigators
|
2.6%
7/270 • Number of events 8 • 96 weeks
AEs reported by investigators
|
|
Reproductive system and breast disorders
Menstrual cycle and uterine bleeding disorders
|
2.6%
7/271 • Number of events 8 • 96 weeks
AEs reported by investigators
|
4.1%
11/270 • Number of events 12 • 96 weeks
AEs reported by investigators
|
|
Musculoskeletal and connective tissue disorders
Muscle disorders
|
5.9%
16/271 • Number of events 18 • 96 weeks
AEs reported by investigators
|
7.0%
19/270 • Number of events 23 • 96 weeks
AEs reported by investigators
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders NEC
|
14.4%
39/271 • Number of events 51 • 96 weeks
AEs reported by investigators
|
16.3%
44/270 • Number of events 53 • 96 weeks
AEs reported by investigators
|
|
Nervous system disorders
Neurological disorders NEC
|
3.7%
10/271 • Number of events 13 • 96 weeks
AEs reported by investigators
|
3.3%
9/270 • Number of events 9 • 96 weeks
AEs reported by investigators
|
|
Eye disorders
Ocular infections, irritations and inflammations
|
3.3%
9/271 • Number of events 10 • 96 weeks
AEs reported by investigators
|
6.3%
17/270 • Number of events 22 • 96 weeks
AEs reported by investigators
|
|
Skin and subcutaneous tissue disorders
Oral soft tissue conditions
|
3.0%
8/271 • Number of events 9 • 96 weeks
AEs reported by investigators
|
3.7%
10/270 • Number of events 11 • 96 weeks
AEs reported by investigators
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, labour, delivery and postpartum conditions
|
1.8%
5/271 • Number of events 5 • 96 weeks
AEs reported by investigators
|
2.2%
6/270 • Number of events 7 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Protozoal infectious disorders
|
7.7%
21/271 • Number of events 40 • 96 weeks
AEs reported by investigators
|
4.8%
13/270 • Number of events 30 • 96 weeks
AEs reported by investigators
|
|
Renal and urinary disorders
Renal disorders (excl nephropathies)
|
3.0%
8/271 • Number of events 9 • 96 weeks
AEs reported by investigators
|
0.74%
2/270 • Number of events 3 • 96 weeks
AEs reported by investigators
|
|
Reproductive system and breast disorders
Reproductive tract disorders NEC
|
1.5%
4/271 • Number of events 4 • 96 weeks
AEs reported by investigators
|
4.4%
12/270 • Number of events 12 • 96 weeks
AEs reported by investigators
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders NEC
|
18.8%
51/271 • Number of events 77 • 96 weeks
AEs reported by investigators
|
21.5%
58/270 • Number of events 112 • 96 weeks
AEs reported by investigators
|
|
Skin and subcutaneous tissue disorders
Skin appendage conditions
|
3.3%
9/271 • Number of events 9 • 96 weeks
AEs reported by investigators
|
3.0%
8/270 • Number of events 9 • 96 weeks
AEs reported by investigators
|
|
General disorders
Sleep disorders and disturbances
|
4.4%
12/271 • Number of events 12 • 96 weeks
AEs reported by investigators
|
3.0%
8/270 • Number of events 8 • 96 weeks
AEs reported by investigators
|
|
Vascular disorders
Vascular haemorrhagic disorders
|
4.4%
12/271 • Number of events 13 • 96 weeks
AEs reported by investigators
|
3.3%
9/270 • Number of events 10 • 96 weeks
AEs reported by investigators
|
|
Vascular disorders
Vascular hypertensive disorders
|
1.5%
4/271 • Number of events 4 • 96 weeks
AEs reported by investigators
|
4.1%
11/270 • Number of events 11 • 96 weeks
AEs reported by investigators
|
|
Infections and infestations
Viral infectious disorders
|
14.8%
40/271 • Number of events 53 • 96 weeks
AEs reported by investigators
|
15.2%
41/270 • Number of events 56 • 96 weeks
AEs reported by investigators
|
|
Reproductive system and breast disorders
Vulvovaginal disorders (excl infections and inflammations)
|
2.6%
7/271 • Number of events 9 • 96 weeks
AEs reported by investigators
|
3.0%
8/270 • Number of events 10 • 96 weeks
AEs reported by investigators
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is a Clinical Trial Agreement signed with each PI detailing the publication policy and disclosure of study's information, in summary: * The Institution, its personnel and the Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the sponsor, except for the purposes of internal training * Publications or presentations of results from the Study will follow the agreement's publication/presentation guidelines
- Publication restrictions are in place
Restriction type: OTHER