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Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01360762
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Addis Ababa University
University of Gondar
Tigray Regional Health Bureau, Tigray Region
Amhara Regional Health Bureau, Amhara Region
Medecins Sans Frontieres, Netherlands
Leishmania East Africa Platform (LEAP)
Drugs for Neglected Diseases
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Visceral Leishmaniosis
HIV-infection/Aids
Intervention Drug: Pentamidine
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
Period Title: Main Study Period (12-month Treatment)
Started 74
Completed 45
Not Completed 29
Reason Not Completed
Lost to Follow-up             7
Death             5
Discontinuation of study drug for safety             1
Patient relapsed             15
Discontinuation             1
Period Title: Whole Study Period
Started [1] 74
Completed 38
Not Completed 36
Reason Not Completed
Lost to Follow-up             10
Death             7
Patient relapsed             18
Discontinuation of study drug for safety             1
[1]
Treatment period and extended treatment period and follow-up period
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
Overall Number of Baseline Participants 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 74 participants
32
(28 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
3
   4.1%
Male
71
  95.9%
Weight  
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 74 participants
50
(44.6 to 53)
Body Mass Index (BMI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
BMI < 18.5 kg/m^2
56
  75.7%
BMI > 18.5 kg/m^2
18
  24.3%
Functional status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
Working
46
  63.0%
Ambulatory
25
  34.2%
Bed ridden
2
   2.7%
[1]
Measure Analysis Population Description: Information for one participant is missing.
Spleen size   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
not palpable
30
  41.1%
Palpable < 5 cm
14
  19.2%
Palpable 5 cm or > 5 cm
29
  39.7%
[1]
Measure Analysis Population Description: 1 Subjects had no spleen size calculation due to ascites.
Total liver span  
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 74 participants
11
(10 to 13)
Total WBC count  
Median (Inter-Quartile Range)
Unit of measure:  cells/µL
Number Analyzed 74 participants
3000
(2300 to 3900)
Neutrophil percent  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of neutrophils
Number Analyzed 74 participants
62.3
(48.4 to 70.6)
Lymphocyte percent  
Median (Inter-Quartile Range)
Unit of measure:  Percentage of lymphocytes
Number Analyzed 74 participants
27.8
(21.9 to 38.5)
Haemoglobin  
Median (Inter-Quartile Range)
Unit of measure:  g/dL
Number Analyzed 74 participants
9.2
(7.7 to 11.1)
Platelet count  
Median (Inter-Quartile Range)
Unit of measure:  Platelets x10^3 / µL
Number Analyzed 74 participants
192
(136 to 274)
Current CD4 count  
Median (Inter-Quartile Range)
Unit of measure:  cells/µL
Number Analyzed 74 participants
127
(85 to 185)
Current CD4 count  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
50 or less
7
   9.5%
51-100
15
  20.3%
101-200
37
  50.0%
201-350
7
   9.5%
more than 350
5
   6.8%
Missing
3
   4.1%
VL status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Primary
31
  41.9%
Relapse
43
  58.1%
[1]
Measure Description: status of visceral leishmaniasis (primary infection or relapse)
Number of VL episodes before inclusion   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
1 episode
27
  62.8%
2 episodes
12
  27.9%
3 episodes
3
   7.0%
4 episodes
1
   2.3%
[1]
Measure Analysis Population Description: There were only 43 subjects out of the 74 total population that were relapse subjects. The other 31 subjects had a primary infection
1.Primary Outcome
Title Probability of Relapse-free Survival
Hide Description Probability of relapse-free survival up to one year after the start of the intervention (PSP) (at month 6 and month 12)
Time Frame up to 1 year after the start of the intervention (PSP)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description:
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage probability
Probability of relapse-free survival at 6 months
79
(67 to 87)
Probability of relapse-free survival at 12 months
71
(59 to 80)
2.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description Number of patients with SAEs which are possibly, probably or definitely drug-related following clinician's assessment or that lead to permanent drug discontinuations during the first year of pentamidine administration
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description:
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.1%
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description During the first year of pentamidine administration for prophylaxis: participants with any drug-related non-serious adverse events (with drug-related defined as possibly, probably or definitely related to primary therapy following physicians assessment) as well as any serious adverse events (drug-related or not)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description:
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
Drug-related non-serious adverse events
30
  40.5%
Any serious adverse event
17
  23.0%
4.Secondary Outcome
Title Number of Treatment Discontinuations and Interruptions
Hide Description Number of treatment discontinuations and interruptions/missed doses.
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description:
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: number of events
Permanent discontinuation 2
Missed more than 1 dose 4
Treatment interruption 0
5.Secondary Outcome
Title Number of Required Additional Interventions
Hide Description The number of required additional clinical interventions/therapeutic procedures
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description:
Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: number of events
Additional IV fluid during PM administration 10
Prolonged hospital observation 2
additional medication during PM infusion 2
Additional IV or oral glucose 1
Time Frame Adverse event data were collected over the whole study period of 30 months (primary study period (12 months), extended study period (6 months) and 12 months follow-up period).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pentamidine Secondary Prophylaxis (PSP)
Hide Arm/Group Description Patients with co-infection of human immunodeficiency virus (HIV) and visceral leishmaniosis (VL), having being treated for VL.
All-Cause Mortality
Pentamidine Secondary Prophylaxis (PSP)
Affected / at Risk (%)
Total   7/74 (9.46%) 
Hide Serious Adverse Events
Pentamidine Secondary Prophylaxis (PSP)
Affected / at Risk (%)
Total   33/74 (44.59%) 
Blood and lymphatic system disorders   
Hypovolemic shock   2/74 (2.70%) 
Eye disorders   
Uveitis   1/74 (1.35%) 
Gastrointestinal disorders   
Diarrhoea   1/74 (1.35%) 
Upper gastro-intestinal haemorrhage   1/74 (1.35%) 
Infections and infestations   
Disseminated tuberculosis   1/74 (1.35%) 
Herpes Zoster   1/74 (1.35%) 
Bacterial Lymphadenitis   1/74 (1.35%) 
Meningitis   1/74 (1.35%) 
Appendicitis   1/74 (1.35%) 
Cellulitis   1/74 (1.35%) 
Giardiasis   1/74 (1.35%) 
Tuberculosis   1/74 (1.35%) 
Tuberculosis of central nervous system   1/74 (1.35%) 
Typhoid fever   1/74 (1.35%) 
Visceral Leishmaniasis   20/74 (27.03%) 
Injury, poisoning and procedural complications   
Limb injury   1/74 (1.35%) 
Metabolism and nutrition disorders   
Hypoglycaemia   1/74 (1.35%) 
Nervous system disorders   
Demyelinating polyneuropathy   1/74 (1.35%) 
Renal and urinary disorders   
Renal failure   2/74 (2.70%) 
Acute renal failure   1/74 (1.35%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia   16/74 (21.62%) 
Skin and subcutaneous tissue disorders   
Stevens-Johnson syndrome   1/74 (1.35%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pentamidine Secondary Prophylaxis (PSP)
Affected / at Risk (%)
Total   71/74 (95.95%) 
Blood and lymphatic system disorders   
Anaemia   9/74 (12.16%) 
Iron deficiency anaemia   1/74 (1.35%) 
Lymphadenopathy   1/74 (1.35%) 
Thrombocytosis   1/74 (1.35%) 
Eye disorders   
Cataract   1/74 (1.35%) 
Allergic conjunctivitis   1/74 (1.35%) 
Eye allergy   2/74 (2.70%) 
Eye degenerative disorder   1/74 (1.35%) 
Iridocyclitis   3/74 (4.05%) 
Night blindness   2/74 (2.70%) 
Ocular hyperaemia   2/74 (2.70%) 
Refraction disorder   1/74 (1.35%) 
Uveitis   1/74 (1.35%) 
Gastrointestinal disorders   
Abdominal pain   4/74 (5.41%) 
Diarrhoea   13/74 (17.57%) 
Dyspepsia   11/74 (14.86%) 
Gastritis   9/74 (12.16%) 
Hemorrhoids   4/74 (5.41%) 
Peptic ulcer   4/74 (5.41%) 
Vomiting   5/74 (6.76%) 
Abdominal distention   1/74 (1.35%) 
Upper abdominal pain   1/74 (1.35%) 
Anal fistula   1/74 (1.35%) 
Ascites   1/74 (1.35%) 
Constipation   2/74 (2.70%) 
Haemorrhagic diarrhoea   1/74 (1.35%) 
Nausea   3/74 (4.05%) 
Pancreatitis   1/74 (1.35%) 
Proctalgia   1/74 (1.35%) 
Proctitis   1/74 (1.35%) 
Toothache   4/74 (5.41%) 
Upper gastrointestinal haemorrhagues   2/74 (2.70%) 
General disorders   
Application site hypersensitivity   2/74 (2.70%) 
Asthenia   1/74 (1.35%) 
Chest pain   10/74 (13.51%) 
Chills   1/74 (1.35%) 
Injection site hypersensitivity   2/74 (2.70%) 
Local swelling   1/74 (1.35%) 
Pain   1/74 (1.35%) 
Pyrexia   10/74 (13.51%) 
Hepatobiliary disorders   
Cholecystitis acute   1/74 (1.35%) 
Immune system disorders   
Hypersensitivity   2/74 (2.70%) 
Infections and infestations   
Abscess limb   1/74 (1.35%) 
Abscess neck   1/74 (1.35%) 
Acarodermatitis   1/74 (1.35%) 
Acute tonsillitis   1/74 (1.35%) 
Amoebiasis   6/74 (8.11%) 
Amoebic dysentery   2/74 (2.70%) 
Anal abscess   1/74 (1.35%) 
Appendicitis   1/74 (1.35%) 
Ascariasis   2/74 (2.70%) 
Atypical pneumonia   7/74 (9.46%) 
Body tinea   2/74 (2.70%) 
Bronchitis   4/74 (5.41%) 
Bronchopneumonia   1/74 (1.35%) 
Carbuncle   3/74 (4.05%) 
Cellulitis   4/74 (5.41%) 
Cerebral toxoplasmosis   2/74 (2.70%) 
Cestode infection   4/74 (5.41%) 
Chlamydial infection   1/74 (1.35%) 
Cystitis   1/74 (1.35%) 
Disseminated tuberculosis   1/74 (1.35%) 
Dysentery   9/74 (12.16%) 
Eye infection   2/74 (2.70%) 
Bacterial eye infection   7/74 (9.46%) 
Folliculitis   2/74 (2.70%) 
Fungal skin infection   1/74 (1.35%) 
Furuncle   1/74 (1.35%) 
Gastroenteritis   16/74 (21.62%) 
Giardiasis   14/74 (18.92%) 
Helminthic infection   7/74 (9.46%) 
Viral hepatitis   1/74 (1.35%) 
Herpes Zoster   6/74 (8.11%) 
Hookworm infection   1/74 (1.35%) 
Hordeolum   1/74 (1.35%) 
Impetigo   3/74 (4.05%) 
Influenza   1/74 (1.35%) 
Intertrigo candida   2/74 (2.70%) 
Isopsoriasis   1/74 (1.35%) 
Lower respiratory tract infection   2/74 (2.70%) 
Lymph node tuberculosis   1/74 (1.35%) 
Bacterial lymphadenitis   1/74 (1.35%) 
Malaria   19/74 (25.68%) 
Meningitis   1/74 (1.35%) 
Nasopharingitis   1/74 (1.35%) 
Oesophageal candidiasis   1/74 (1.35%) 
Oral candidiasis   3/74 (4.05%) 
Oral herpes   1/74 (1.35%) 
Otitis media   1/74 (1.35%) 
Acute otitis media   1/74 (1.35%) 
Periorbital cellulitis   1/74 (1.35%) 
Bacterial peritonitis   1/74 (1.35%) 
Plasmodium falciparum infection   3/74 (4.05%) 
Plasmodium vivax infection   8/74 (10.81%) 
Pneumonia   32/74 (43.24%) 
Pulmonary tuberculosis   1/74 (1.35%) 
Pulpitis dental   1/74 (1.35%) 
Pyomyositis   1/74 (1.35%) 
Respiratory tract infection   1/74 (1.35%) 
Sepsis   1/74 (1.35%) 
Sinusitis   1/74 (1.35%) 
Skin infection   2/74 (2.70%) 
Strongyloidiasis   3/74 (4.05%) 
Subcutaneous abscess   1/74 (1.35%) 
Syphilis   1/74 (1.35%) 
Taeniasis   1/74 (1.35%) 
Tonsillitis   1/74 (1.35%) 
Tuberculosis   3/74 (4.05%) 
Tuberculosis of central nervous system   1/74 (1.35%) 
Typhoid fever   2/74 (2.70%) 
Upper respiratory tract infection   7/74 (9.46%) 
Urinary tract infection   10/74 (13.51%) 
Visceral leishmaniasis   21/74 (28.38%) 
Wound infection   2/74 (2.70%) 
Injury, poisoning and procedural complications   
Accident at work   1/74 (1.35%) 
Animal bite   2/74 (2.70%) 
Chest injury   1/74 (1.35%) 
Excoriation   2/74 (2.70%) 
Laceration   1/74 (1.35%) 
Limb injury   1/74 (1.35%) 
Muscle strain   2/74 (2.70%) 
Soft tissue injury   4/74 (5.41%) 
Wound   1/74 (1.35%) 
Investigations   
Blood albumin decreased   1/74 (1.35%) 
Blood alkaline phosphatase increased   2/74 (2.70%) 
Blood creatinine increased   2/74 (2.70%) 
Creatinine renal clearance decreased   1/74 (1.35%) 
Platelet count decreased   1/74 (1.35%) 
Weight decreased   1/74 (1.35%) 
Metabolism and nutrition disorders   
Decreased appetite   11/74 (14.86%) 
Dehydration   1/74 (1.35%) 
Hyperglycemia   1/74 (1.35%) 
Hypoglycaemia   4/74 (5.41%) 
Hypokalaemia   1/74 (1.35%) 
Hypovitaminosis   3/74 (4.05%) 
Tetany   1/74 (1.35%) 
Arthralgia   14/74 (18.92%) 
Back pain   4/74 (5.41%) 
Myalgia   2/74 (2.70%) 
Pain in extremity   3/74 (4.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anogenital warts   1/74 (1.35%) 
Nervous system disorders   
Convulsion   1/74 (1.35%) 
Demyelinating polyneuropathy   1/74 (1.35%) 
Dizziness   1/74 (1.35%) 
Headache   8/74 (10.81%) 
Migraine   2/74 (2.70%) 
Myelopathy   1/74 (1.35%) 
Neuralgia   1/74 (1.35%) 
Peripheral neuropathy   8/74 (10.81%) 
Polyneuropathy   1/74 (1.35%) 
Post herpetic neuropathy   1/74 (1.35%) 
Psychiatric disorders   
Anxiety   1/74 (1.35%) 
Somatoform disorder   1/74 (1.35%) 
Renal and urinary disorders   
Renal failure   2/74 (2.70%) 
Acute renal failure   2/74 (2.70%) 
Renal impairment   1/74 (1.35%) 
Urethral discharge   3/74 (4.05%) 
Reproductive system and breast disorders   
Genital ulceration   1/74 (1.35%) 
Gynaecomastia   1/74 (1.35%) 
Scrotal swelling   2/74 (2.70%) 
Testicular swelling   1/74 (1.35%) 
Respiratory, thoracic and mediastinal disorders   
Bronchial hyperreactivity   2/74 (2.70%) 
Cough   4/74 (5.41%) 
Epistaxis   1/74 (1.35%) 
Haemoptysis   1/74 (1.35%) 
Nasal congestion   16/74 (21.62%) 
Skin and subcutaneous tissue disorders   
Acne   1/74 (1.35%) 
Cold urticaria   1/74 (1.35%) 
Dandruff   1/74 (1.35%) 
Allergic dermatitis   3/74 (4.05%) 
Contact dermatitis   1/74 (1.35%) 
Eczema   1/74 (1.35%) 
Pruritus   5/74 (6.76%) 
Psoriasis   2/74 (2.70%) 
Rash   4/74 (5.41%) 
Skin hypopigmentation   1/74 (1.35%) 
Skin lesion   1/74 (1.35%) 
Skin reaction   1/74 (1.35%) 
Stevens-Johnson syndrome   1/74 (1.35%) 
Subcutaneous emphysema   1/74 (1.35%) 
Vascular disorders   
Hypotension   13/74 (17.57%) 
Hypovolaemic shock   2/74 (2.70%) 
Shock   1/74 (1.35%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Johan Van Griensven
Organization: Institute of Tropical Medicine Antwerp
Phone: +32(0)32476426
EMail: jvangriensven@itg.be
Layout table for additonal information
Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT01360762    
Other Study ID Numbers: ITMC0109
First Submitted: May 24, 2011
First Posted: May 26, 2011
Results First Submitted: February 9, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019