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Trial record 13 of 3106 for:    HIV Infections | NIH

Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

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: NCT00016718
Recruitment Status : Completed
First Posted : August 31, 2001
Results First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Didanosine (ddI)
Drug: Efavirenz (EFV)
Drug: Emtricitabine (FTC)
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Age Group 1 Age Group 2 Age Group 3
Hide Arm/Group Description 90 days to < 3 years of age, inclusive (FTC, EFV, ddI) 3 years to 12 years of age, inclusive (FTC, EFV, ddI) 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Period Title: Overall Study
Started 6 21 16
Completed 6 21 16
Not Completed 0 0 0
Arm/Group Title Age Group 1 Age Group 2 Age Group 3 Total
Hide Arm/Group Description 90 days to < 3 years of age, inclusive (FTC, EFV, ddI) 3 years to 12 years of age, inclusive (FTC, EFV, ddI) 13 years to 21 years of age, inclusive (FTC, EFV, ddI) Total of all reporting groups
Overall Number of Baseline Participants 6 21 16 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 21 participants 16 participants 43 participants
0.5
(0.3 to 2.6)
5.7
(3.2 to 11.7)
17.5
(14.5 to 21.1)
9.6
(0.3 to 21.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 21 participants 16 participants 43 participants
Female
4
  66.7%
11
  52.4%
6
  37.5%
21
  48.8%
Male
2
  33.3%
10
  47.6%
10
  62.5%
22
  51.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 21 participants 16 participants 43 participants
White non-Hispanic
0
   0.0%
3
  14.3%
2
  12.5%
5
  11.6%
Black non-Hispanic
4
  66.7%
11
  52.4%
12
  75.0%
27
  62.8%
Hispanic
2
  33.3%
7
  33.3%
2
  12.5%
11
  25.6%
1.Primary Outcome
Title Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.
Hide Description

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment.

Comparisons between age groups were not required as per protocol.

Time Frame At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
All Participant who enrolled in the study
Arm/Group Title Age Group 1 Age Group 2 Age Group 3
Hide Arm/Group Description:
90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
3 years to 12 years of age, inclusive (FTC, EFV, ddI)
13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Overall Number of Participants Analyzed 6 21 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.17
(0.03 to 0.56)
0.1
(0.03 to 0.29)
0.19
(0.07 to 0.43)
2.Primary Outcome
Title Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16
Time Frame At week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All Participant who enrolled in the study and with available HIV-RNA at week 16
Arm/Group Title Age Group 1 Age Group 2 Age Group 3
Hide Arm/Group Description:
90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
3 years to 12 years of age, inclusive (FTC, EFV, ddI)
13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Overall Number of Participants Analyzed 6 21 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.83
(0.36 to 0.99)
0.86
(0.64 to 0.97)
0.81
(0.54 to 0.96)
3.Primary Outcome
Title Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16
Time Frame At week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All Participant who enrolled in the study and with available HIV-RNA at week 16
Arm/Group Title Age Group 1 Age Group 2 Age Group 3
Hide Arm/Group Description:
90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
3 years to 12 years of age, inclusive (FTC, EFV, ddI)
13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Overall Number of Participants Analyzed 6 21 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.50
(0.12 to 0.88)
0.76
(0.53 to 0.92)
0.75
(0.48 to 0.93)
Time Frame At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Group 2 and 3 participants
Adverse Event Reporting Description The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events .Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/).
 
Arm/Group Title Age Group 1 Age Group 2 Age Group 3
Hide Arm/Group Description 90 days to 3 years of age, inclusive (FTC, EFV, ddI) 3 years to 12 years of age, inclusive (FTC, EFV, ddI) 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
All-Cause Mortality
Age Group 1 Age Group 2 Age Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Age Group 1 Age Group 2 Age Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   4/21 (19.05%)   5/16 (31.25%) 
Gastrointestinal disorders       
Abdominal pain  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Diarrhoea  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Investigations       
Blood creatine phosphokinase increased  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Blood glucose decreased  1  0/6 (0.00%)  1/21 (4.76%)  0/16 (0.00%) 
Gamma-glutamyltransferase increased  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Liver function test increased  1  0/6 (0.00%)  1/21 (4.76%)  0/16 (0.00%) 
Neutrophil count decreased  1  0/6 (0.00%)  1/21 (4.76%)  0/16 (0.00%) 
Nervous system disorders       
Dizziness  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Psychiatric disorders       
Psychotic disorder  1  0/6 (0.00%)  1/21 (4.76%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Age Group 1 Age Group 2 Age Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   21/21 (100.00%)   16/16 (100.00%) 
Blood and lymphatic system disorders       
Lymphadenitis  1  0/6 (0.00%)  1/21 (4.76%)  4/16 (25.00%) 
Lymphadenopathy  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Neutropenia  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Congenital, familial and genetic disorders       
Cerebral palsy  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Congenital nystagmus  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Microcephaly  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Ear and labyrinth disorders       
Ear pain  1  0/6 (0.00%)  3/21 (14.29%)  1/16 (6.25%) 
Otorrhoea  1  1/6 (16.67%)  1/21 (4.76%)  0/16 (0.00%) 
Tympanic membrane hyperaemia  1  1/6 (16.67%)  1/21 (4.76%)  0/16 (0.00%) 
Eye disorders       
Blepharospasm  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Blindness  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Eye discharge  1  2/6 (33.33%)  1/21 (4.76%)  0/16 (0.00%) 
Ocular hyperaemia  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Pupil fixed  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Vision blurred  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Gastrointestinal disorders       
Abdominal discomfort  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Abdominal pain  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Constipation  1  0/6 (0.00%)  0/21 (0.00%)  3/16 (18.75%) 
Diarrhoea  1  5/6 (83.33%)  4/21 (19.05%)  0/16 (0.00%) 
Gastritis  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Gastrooesophageal reflux disease  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Gingival hypertrophy  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Lip swelling  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Nausea  1  0/6 (0.00%)  0/21 (0.00%)  4/16 (25.00%) 
Periodontal disease  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Proctalgia  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Toothache  1  0/6 (0.00%)  1/21 (4.76%)  2/16 (12.50%) 
Vomiting  1  3/6 (50.00%)  1/21 (4.76%)  3/16 (18.75%) 
General disorders       
Asthenia  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Chills  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Dysplasia  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Fatigue  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Localised oedema  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Mass  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Peripheral swelling  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Pyrexia  1  3/6 (50.00%)  7/21 (33.33%)  3/16 (18.75%) 
Secretion discharge  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Infections and infestations       
Acarodermatitis  1  0/6 (0.00%)  4/21 (19.05%)  1/16 (6.25%) 
Acute sinusitis  1  0/6 (0.00%)  4/21 (19.05%)  7/16 (43.75%) 
Atypical mycobacterial lymphadenitis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Bacterial vaginosis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Body tinea  1  0/6 (0.00%)  3/21 (14.29%)  4/16 (25.00%) 
Bronchitis  1  1/6 (16.67%)  0/21 (0.00%)  2/16 (12.50%) 
Cellulitis  1  0/6 (0.00%)  1/21 (4.76%)  1/16 (6.25%) 
Cervicitis human papilloma virus  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Conjunctivitis  1  2/6 (33.33%)  0/21 (0.00%)  0/16 (0.00%) 
Coxsackie viral infection  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Epididymitis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Gastroenteritis  1  1/6 (16.67%)  5/21 (23.81%)  1/16 (6.25%) 
Gastroenteritis rotavirus  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Genital herpes simplex  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Genital infection bacterial  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Gingivitis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Herpes zoster  1  0/6 (0.00%)  1/21 (4.76%)  1/16 (6.25%) 
Impetigo  1  0/6 (0.00%)  5/21 (23.81%)  0/16 (0.00%) 
Latent tuberculosis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Onychomycosis  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Oral candidiasis  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Oral herpes  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Otitis externa  1  0/6 (0.00%)  2/21 (9.52%)  0/16 (0.00%) 
Otitis media  1  1/6 (16.67%)  8/21 (38.10%)  0/16 (0.00%) 
Otitis media acute  1  1/6 (16.67%)  5/21 (23.81%)  0/16 (0.00%) 
Otitis media bacterial  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Papilloma viral infection  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Parotitis  1  0/6 (0.00%)  2/21 (9.52%)  0/16 (0.00%) 
Pharyngitis  1  0/6 (0.00%)  3/21 (14.29%)  1/16 (6.25%) 
Pneumonia  1  0/6 (0.00%)  2/21 (9.52%)  0/16 (0.00%) 
Purulent discharge  1  0/6 (0.00%)  2/21 (9.52%)  0/16 (0.00%) 
Salpingitis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Skin candida  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Tinea capitis  1  1/6 (16.67%)  4/21 (19.05%)  0/16 (0.00%) 
Tinea cruris  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Tinea infection  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Tinea pedis  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Trichomoniasis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Urethritis  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Urethritis gonococcal  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Urinary tract infection staphylococcal  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Varicella  1  0/6 (0.00%)  2/21 (9.52%)  0/16 (0.00%) 
Vulvovaginal candidiasis  1  0/6 (0.00%)  1/21 (4.76%)  1/16 (6.25%) 
Vulvovaginal mycotic infection  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Vulvovaginitis  1  0/6 (0.00%)  1/21 (4.76%)  2/16 (12.50%) 
Vulvovaginitis trichomonal  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Investigations       
Alanine aminotransferase increased  1  3/6 (50.00%)  12/21 (57.14%)  5/16 (31.25%) 
Aldolase abnormal  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Aspartate aminotransferase increased  1  3/6 (50.00%)  15/21 (71.43%)  10/16 (62.50%) 
Blood alkaline phosphatase increased  1  5/6 (83.33%)  11/21 (52.38%)  4/16 (25.00%) 
Blood bilirubin increased  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Blood calcium decreased  1  0/6 (0.00%)  9/21 (42.86%)  1/16 (6.25%) 
Blood calcium increased  1  4/6 (66.67%)  0/21 (0.00%)  3/16 (18.75%) 
Blood cholesterol increased  1  4/6 (66.67%)  16/21 (76.19%)  11/16 (68.75%) 
Blood creatine phosphokinase abnormal  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Blood creatine phosphokinase increased  1  1/6 (16.67%)  5/21 (23.81%)  3/16 (18.75%) 
Blood creatinine increased  1  0/6 (0.00%)  10/21 (47.62%)  12/16 (75.00%) 
Blood glucose abnormal  1  0/6 (0.00%)  1/21 (4.76%)  1/16 (6.25%) 
Blood glucose decreased  1  4/6 (66.67%)  11/21 (52.38%)  6/16 (37.50%) 
Blood glucose increased  1  3/6 (50.00%)  8/21 (38.10%)  12/16 (75.00%) 
Blood magnesium decreased  1  0/6 (0.00%)  3/21 (14.29%)  0/16 (0.00%) 
Blood potassium decreased  1  0/6 (0.00%)  6/21 (28.57%)  9/16 (56.25%) 
Blood potassium increased  1  5/6 (83.33%)  8/21 (38.10%)  4/16 (25.00%) 
Blood sodium decreased  1  5/6 (83.33%)  17/21 (80.95%)  6/16 (37.50%) 
Blood sodium increased  1  0/6 (0.00%)  1/21 (4.76%)  5/16 (31.25%) 
Blood triglycerides abnormal  1  0/6 (0.00%)  2/21 (9.52%)  4/16 (25.00%) 
Blood triglycerides increased  1  6/6 (100.00%)  19/21 (90.48%)  13/16 (81.25%) 
Blood urea abnormal  1  0/6 (0.00%)  5/21 (23.81%)  1/16 (6.25%) 
Blood uric acid increased  1  0/6 (0.00%)  0/21 (0.00%)  3/16 (18.75%) 
Haemoglobin decreased  1  4/6 (66.67%)  13/21 (61.90%)  2/16 (12.50%) 
Neutrophil count decreased  1  4/6 (66.67%)  16/21 (76.19%)  5/16 (31.25%) 
Pancreatic enzymes abnormal  1  1/6 (16.67%)  3/21 (14.29%)  1/16 (6.25%) 
Total cholesterol/HDL ratio abnormal  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Weight decreased  1  0/6 (0.00%)  1/21 (4.76%)  1/16 (6.25%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Dehydration  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Joint range of motion decreased  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Myalgia  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Osteopenia  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Pain in extremity  1  0/6 (0.00%)  1/21 (4.76%)  1/16 (6.25%) 
Pain in jaw  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Carcinoma in situ  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Skin papilloma  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Nervous system disorders       
Coordination abnormal  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Encephalopathy  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Febrile convulsion  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Headache  1  0/6 (0.00%)  1/21 (4.76%)  5/16 (31.25%) 
Hypertonia  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Hypoaesthesia  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Hypotonia  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Migraine  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Muscle spasticity  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Neurological symptom  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Neuropathy peripheral  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Paraesthesia  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Poor sucking reflex  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Seizure  1  2/6 (33.33%)  0/21 (0.00%)  0/16 (0.00%) 
Somnolence  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Syncope  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Pregnancy  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Psychiatric disorders       
Bulimia nervosa  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Depression  1  0/6 (0.00%)  0/21 (0.00%)  3/16 (18.75%) 
Insomnia  1  0/6 (0.00%)  0/21 (0.00%)  3/16 (18.75%) 
Major depression  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Nightmare  1  0/6 (0.00%)  3/21 (14.29%)  2/16 (12.50%) 
Post-traumatic stress disorder  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Sleep disorder  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Renal and urinary disorders       
Dysuria  1  0/6 (0.00%)  1/21 (4.76%)  3/16 (18.75%) 
Polyuria  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Reproductive system and breast disorders       
Amenorrhoea  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Cervical dysplasia  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Genital lesion  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Penile discharge  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Scrotal pain  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Scrotal swelling  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Vaginal discharge  1  0/6 (0.00%)  1/21 (4.76%)  2/16 (12.50%) 
Vaginal haemorrhage  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/6 (16.67%)  1/21 (4.76%)  0/16 (0.00%) 
Bronchial hyperreactivity  1  1/6 (16.67%)  1/21 (4.76%)  0/16 (0.00%) 
Cough  1  2/6 (33.33%)  8/21 (38.10%)  3/16 (18.75%) 
Dyspnoea  1  1/6 (16.67%)  0/21 (0.00%)  2/16 (12.50%) 
Nasal congestion  1  0/6 (0.00%)  4/21 (19.05%)  0/16 (0.00%) 
Oropharyngeal pain  1  0/6 (0.00%)  2/21 (9.52%)  1/16 (6.25%) 
Paranasal sinus hypersecretion  1  1/6 (16.67%)  0/21 (0.00%)  1/16 (6.25%) 
Rhinorrhoea  1  2/6 (33.33%)  3/21 (14.29%)  2/16 (12.50%) 
Sinus congestion  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Wheezing  1  1/6 (16.67%)  1/21 (4.76%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders       
Acne  1  0/6 (0.00%)  0/21 (0.00%)  4/16 (25.00%) 
Dermatitis atopic  1  1/6 (16.67%)  0/21 (0.00%)  0/16 (0.00%) 
Dermatitis diaper  1  2/6 (33.33%)  0/21 (0.00%)  0/16 (0.00%) 
Eczema  1  1/6 (16.67%)  2/21 (9.52%)  1/16 (6.25%) 
Erythema multiforme  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Pityriasis rosea  1  0/6 (0.00%)  0/21 (0.00%)  2/16 (12.50%) 
Pruritus  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Pruritus generalised  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Rash  1  2/6 (33.33%)  2/21 (9.52%)  1/16 (6.25%) 
Rash erythematous  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Rash generalised  1  0/6 (0.00%)  2/21 (9.52%)  4/16 (25.00%) 
Rash papular  1  0/6 (0.00%)  1/21 (4.76%)  1/16 (6.25%) 
Scab  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Skin hyperpigmentation  1  0/6 (0.00%)  4/21 (19.05%)  0/16 (0.00%) 
Skin lesion  1  1/6 (16.67%)  0/21 (0.00%)  1/16 (6.25%) 
Swelling face  1  0/6 (0.00%)  3/21 (14.29%)  0/16 (0.00%) 
Vascular disorders       
Hypertension  1  0/6 (0.00%)  0/21 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
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.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00016718     History of Changes
Other Study ID Numbers: P1021
10038 ( Registry Identifier: DAIDS ES )
ACTG P1021
PACTG P1021
IMPAACT P1021
First Submitted: May 31, 2001
First Posted: August 31, 2001
Results First Submitted: August 1, 2017
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017