Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00099359
First received: December 10, 2004
Last updated: October 26, 2012
Last verified: February 2011
Results First Received: April 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Disease Transmission, Vertical
Vertical Human Immunodeficiency Virus Transmission
HIV Infections
Interventions: Drug: Zidovudine
Drug: Nevirapine (NVP)
Drug: Epivir (3TC)
Drug: Nelfinavir (NFV)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was enrolled on 02/27/2004 and the study ended 02/28/2011. A total of 17 sites in Brazil, South Africa, Argentina and the U.S. participated in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A (ZDV Only) Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
ARM B (ZDV + NVP)

Standard of care (Zidovudine) plus Nevirapine (NVP)

NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :

12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams

ARM C (ZDV + 3TC + NFV)

Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND

NFV, given for 2 weeks:

200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams


Participant Flow:   Overall Study
    Arm A (ZDV Only)     ARM B (ZDV + NVP)     ARM C (ZDV + 3TC + NFV)  
STARTED     581     580     574  
COMPLETED     527     515     506  
NOT COMPLETED     54     65     68  
Death                 11                 15                 17  
Withdrawal by Subject                 19                 19                 23  
Lost to Follow-up                 15                 24                 24  
moved out of area                 9                 7                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A (ZDV Only) Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
ARM B (ZDV + NVP)

Standard of care (Zidovudine) plus Nevirapine (NVP)

NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :

12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams

ARM C (ZDV + 3TC + NFV)

Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND

NFV, given for 2 weeks:

200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams

Total Total of all reporting groups

Baseline Measures
    Arm A (ZDV Only)     ARM B (ZDV + NVP)     ARM C (ZDV + 3TC + NFV)     Total  
Number of Participants  
[units: participants]
  581     580     574     1735  
Age  
[units: weeks]
Mean ± Standard Deviation
       
Gestational Age in Weeks     39  ± 1.7     39  ± 1.5     39  ± 1.7     39  ± 1.7  
Gender  
[units: participants]
       
Female     298     303     281     882  
Male     283     277     293     853  
Region of Enrollment  
[units: participants]
       
United States     4     4     4     12  
Puerto Rico     0     1     1     2  
Argentina     10     6     11     27  
Brazil     409     408     402     1219  
South Africa     158     161     156     475  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Infant HIV Infection Status   [ Time Frame: 3 months ]

2.  Primary:   Participants With Serious Adverse Events   [ Time Frame: through age 6 months. ]

3.  Secondary:   Infant HIV-1 Infection Status   [ Time Frame: birth ]

4.  Secondary:   Participant Deaths   [ Time Frame: through age 6 months ]

5.  Secondary:   3TC and NFV Pharmacokinetics   [ Time Frame: through age 14 days ]

6.  Secondary:   Risk Factors for Perinatal HIV-1 Transmission   [ Time Frame: through age 3 months ]

7.  Secondary:   NVP Pharmacokinetics   [ Time Frame: 14 days ]

8.  Secondary:   Clinical Covariates of HIV-1 Infection   [ Time Frame: through age 3 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame through 6 months
Additional Description AE data collected from study entry to off study period

Reporting Groups
  Description
ARM A (ZDV Alone)

ZDV, given for 6 weeks:

12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams

ARM B (ZDV + NVP)

ZDV, given for 6 weeks:

12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams

AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :

12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams

ARM C (ZDV + 3TC/NFV)

ZDV, given for 6 weeks:

12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND

NFV, given for 2 weeks:

200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams


Serious Adverse Events
    ARM A (ZDV Alone)     ARM B (ZDV + NVP)     ARM C (ZDV + 3TC/NFV)  
Total, serious adverse events        
# participants affected / at risk     219/581 (37.69%)     211/580 (36.38%)     252/574 (43.90%)  
Blood and lymphatic system disorders        
Anaemia Nos † 1      
# participants affected / at risk     48/581 (8.26%)     28/580 (4.83%)     39/574 (6.79%)  
# events     51     32     46  
Axillary Lymphadenitis † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Disseminated Intravascular Coagulation † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Isoimmune Haemolytic Disease † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     3     0  
Leukocytosis † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Neutropenia † 1      
# participants affected / at risk     33/581 (5.68%)     33/580 (5.69%)     71/574 (12.37%)  
# events     34     40     83  
Polycythaemia Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Thrombocythaemia † 1      
# participants affected / at risk     3/581 (0.52%)     0/580 (0.00%)     1/574 (0.17%)  
# events     3     0     1  
Thrombocytopenia † 1      
# participants affected / at risk     5/581 (0.86%)     4/580 (0.69%)     9/574 (1.57%)  
# events     5     4     10  
Cardiac disorders        
Cardio-Respiratory Arrest † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Cyanosis Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Pulmonary Valve Stenosis † 1      
# participants affected / at risk     1/581 (0.17%)     2/580 (0.34%)     2/574 (0.35%)  
# events     1     2     2  
Tachycardia Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Tricuspid Valve Incompetence † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Cardiac Disorder Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Cardiac Failure Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Congenital Cardiac Septal Defect Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Congenital, familial and genetic disorders        
Congenital Atrial Septal Defect † 1      
# participants affected / at risk     5/581 (0.86%)     4/580 (0.69%)     4/574 (0.70%)  
# events     5     4     4  
Congenital Choroid Plexus Cyst † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Congenital Clubfoot † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     1/574 (0.17%)  
# events     0     1     1  
Congenital Cytomegalovirus Infection † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Congenital Infection Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Congenital Macrocephaly † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Congenital Syphilis † 1      
# participants affected / at risk     47/581 (8.09%)     52/580 (8.97%)     42/574 (7.32%)  
# events     47     52     43  
Congenital Toxoplasmosis † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     1/574 (0.17%)  
# events     1     0     1  
Congenital Ventricular Septal Defect † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     2/574 (0.35%)  
# events     1     0     2  
Foetal Alcohol Syndrome † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Genitalia External Ambiguous † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Meningomyelocele † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Patent Ductus Arteriosus † 1      
# participants affected / at risk     0/581 (0.00%)     2/580 (0.34%)     1/574 (0.17%)  
# events     0     2     1  
Retinoblastoma Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Trisomy 21 † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     1/574 (0.17%)  
# events     1     1     1  
Urethral Valves † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Eye disorders        
Neonatal Conjunctivitis Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Gastrointestinal disorders        
Acquired Pyloric Stenosis † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Constipation † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Diarrhoea Nos † 1      
# participants affected / at risk     4/581 (0.69%)     4/580 (0.69%)     6/574 (1.05%)  
# events     4     4     6  
Gastrooesophageal Reflux Disease † 1      
# participants affected / at risk     2/581 (0.34%)     1/580 (0.17%)     3/574 (0.52%)  
# events     2     1     3  
Haematochezia † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Ileus † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Intestinal Obstruction Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Intestinal Perforation Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Vomiting Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     2/574 (0.35%)  
# events     0     1     2  
General disorders        
Drug Withdrawal Syndrome Neonatal † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     0/574 (0.00%)  
# events     1     1     0  
Multi-Organ Failure † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     0/574 (0.00%)  
# events     1     1     0  
Pyrexia † 1      
# participants affected / at risk     5/581 (0.86%)     5/580 (0.86%)     1/574 (0.17%)  
# events     5     5     1  
Sudden Infant Death Syndrome † 1      
# participants affected / at risk     1/581 (0.17%)     2/580 (0.34%)     5/574 (0.87%)  
# events     1     2     5  
Hepatobiliary disorders        
Hyperbilirubinaemia † 1      
# participants affected / at risk     2/581 (0.34%)     1/580 (0.17%)     1/574 (0.17%)  
# events     2     1     1  
Jaundice Nos † 1      
# participants affected / at risk     10/581 (1.72%)     3/580 (0.52%)     2/574 (0.35%)  
# events     10     3     2  
Infections and infestations        
Abscess Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Arthritis Bacterial † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Breast Abscess † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Bronchiolitis † 1      
# participants affected / at risk     13/581 (2.24%)     28/580 (4.83%)     15/574 (2.61%)  
# events     14     30     17  
Bronchitis Acute Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Bronchopneumonia Nos † 1      
# participants affected / at risk     3/581 (0.52%)     9/580 (1.55%)     8/574 (1.39%)  
# events     3     9     9  
Cellulitis † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     1/574 (0.17%)  
# events     1     0     1  
Cellulitis Gangrenous † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Conjunctivitis Infective † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Febrile Infection † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Gastroenteritis Nos † 1      
# participants affected / at risk     21/581 (3.61%)     19/580 (3.28%)     16/574 (2.79%)  
# events     24     21     18  
Gastrointestinal Infection Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Impetigo Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     2/574 (0.35%)  
# events     0     1     2  
Lobar Pneumonia Nos † 1      
# participants affected / at risk     2/581 (0.34%)     0/580 (0.00%)     0/574 (0.00%)  
# events     2     0     0  
Lower Respiratory Tract Infection Nos † 1      
# participants affected / at risk     3/581 (0.52%)     2/580 (0.34%)     0/574 (0.00%)  
# events     3     2     0  
Mastitis † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Meningitis † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     1/574 (0.17%)  
# events     1     1     1  
Meningitis Pneumococcal † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Neonatal Infection Nos † 1      
# participants affected / at risk     5/581 (0.86%)     1/580 (0.17%)     2/574 (0.35%)  
# events     5     1     2  
Omphalitis † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Oral Candidiasis † 1      
# participants affected / at risk     3/581 (0.52%)     1/580 (0.17%)     2/574 (0.35%)  
# events     3     1     2  
Otitis Media Acute Nos † 1      
# participants affected / at risk     2/581 (0.34%)     1/580 (0.17%)     0/574 (0.00%)  
# events     2     1     0  
Parainfluenzae Virus Infection Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Periorbital Cellulitis † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Pertussis † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Pneumocystis Carinii Infection † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Pneumocystis Carinii Pneumonia † 1      
# participants affected / at risk     3/581 (0.52%)     0/580 (0.00%)     0/574 (0.00%)  
# events     3     0     0  
Pneumonia Nos † 1      
# participants affected / at risk     22/581 (3.79%)     17/580 (2.93%)     18/574 (3.14%)  
# events     23     17     19  
Pulmonary Tuberculosis † 1      
# participants affected / at risk     1/581 (0.17%)     2/580 (0.34%)     0/574 (0.00%)  
# events     1     2     0  
Respiratory Syncytial Virus Infection Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Respiratory Tract Infection Nos † 1      
# participants affected / at risk     2/581 (0.34%)     4/580 (0.69%)     2/574 (0.35%)  
# events     2     4     2  
Scabies Infestation † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Sepsis Neonatal † 1      
# participants affected / at risk     5/581 (0.86%)     3/580 (0.52%)     4/574 (0.70%)  
# events     5     3     4  
Sepsis Nos † 1      
# participants affected / at risk     21/581 (3.61%)     16/580 (2.76%)     23/574 (4.01%)  
# events     21     18     24  
Septic Shock † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Tuberculosis Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Umbilical Cord Sepsis Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Upper Respiratory Tract Infection Nos † 1      
# participants affected / at risk     0/581 (0.00%)     2/580 (0.34%)     1/574 (0.17%)  
# events     0     2     1  
Urinary Tract Infection Nos † 1      
# participants affected / at risk     0/581 (0.00%)     4/580 (0.69%)     3/574 (0.52%)  
# events     0     4     3  
Varicella † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Injury, poisoning and procedural complications        
Clavicle Fracture † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Fall † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Femur Fracture † 1      
# participants affected / at risk     0/581 (0.00%)     2/580 (0.34%)     0/574 (0.00%)  
# events     0     2     0  
Head Injury † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Hypothermia † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Investigations        
Acoustic Stimulation Tests Abnormal † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Alanine Aminotransferase Increased † 1      
# participants affected / at risk     12/581 (2.07%)     7/580 (1.21%)     5/574 (0.87%)  
# events     13     8     6  
Aspartate Aminotransferase Increased † 1      
# participants affected / at risk     14/581 (2.41%)     7/580 (1.21%)     11/574 (1.92%)  
# events     15     8     13  
Blood Calcium Increased † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Blood Creatinine Increased † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Blood Potassium Increased † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     2/574 (0.35%)  
# events     0     0     2  
Blood Urea Increased † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Cardiac Murmur Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
General Physical Condition Abnormal † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Weight Decreased † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Metabolism and nutrition disorders        
Dehydration † 1      
# participants affected / at risk     8/581 (1.38%)     2/580 (0.34%)     3/574 (0.52%)  
# events     8     2     3  
Electrolyte Imbalance † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Failure To Thrive † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     2/574 (0.35%)  
# events     0     0     2  
Feeding Problem In Newborn † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
General Nutrition Disorder † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Hyperglycaemia Nos † 1      
# participants affected / at risk     0/581 (0.00%)     2/580 (0.34%)     0/574 (0.00%)  
# events     0     2     0  
Hyperkalaemia † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Hypernatraemia † 1      
# participants affected / at risk     3/581 (0.52%)     5/580 (0.86%)     2/574 (0.35%)  
# events     3     5     2  
Hypocalcaemia † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Hypoglycaemia Nos † 1      
# participants affected / at risk     2/581 (0.34%)     1/580 (0.17%)     2/574 (0.35%)  
# events     2     1     2  
Hypokalaemia † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Hyponatraemia † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     1/574 (0.17%)  
# events     1     1     1  
Malnutrition Nos † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     0/574 (0.00%)  
# events     1     1     0  
Marasmus † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Metabolic Acidosis Nos † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     1/574 (0.17%)  
# events     1     1     1  
Underweight † 1      
# participants affected / at risk     0/581 (0.00%)     2/580 (0.34%)     0/574 (0.00%)  
# events     0     2     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Tongue Neoplasm Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Nervous system disorders        
Cerebral Thrombosis Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Convulsions Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     2/574 (0.35%)  
# events     0     1     2  
Encephalitis Nos † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     0/574 (0.00%)  
# events     1     1     0  
Hydrocephalus † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     0/574 (0.00%)  
# events     2     1     0  
Poor Sucking Reflex † 1      
# participants affected / at risk     2/581 (0.34%)     1/580 (0.17%)     0/574 (0.00%)  
# events     2     1     0  
Visual Field Defect Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Pregnancy, puerperium and perinatal conditions        
Jaundice Neonatal † 1      
# participants affected / at risk     10/581 (1.72%)     3/580 (0.52%)     6/574 (1.05%)  
# events     10     3     6  
Premature Baby † 1      
# participants affected / at risk     5/581 (0.86%)     6/580 (1.03%)     10/574 (1.74%)  
# events     5     6     10  
Small For Dates Baby † 1      
# participants affected / at risk     3/581 (0.52%)     3/580 (0.52%)     9/574 (1.57%)  
# events     3     3     9  
Renal and urinary disorders        
Renal Failure Nos † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     1/574 (0.17%)  
# events     1     1     1  
Urinary Retention † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     2     0  
Respiratory, thoracic and mediastinal disorders        
Apnoea † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Asphyxia † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Asthma Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Bronchitis Nos † 1      
# participants affected / at risk     1/581 (0.17%)     1/580 (0.17%)     0/574 (0.00%)  
# events     1     1     0  
Bronchospasm Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Cough † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     1/574 (0.17%)  
# events     0     1     1  
Cyanosis Neonatal † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Dyspnoea † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Neonatal Aspiration † 1      
# participants affected / at risk     0/581 (0.00%)     2/580 (0.34%)     1/574 (0.17%)  
# events     0     2     1  
Obstructive Airways Disorder Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Pneumonia Aspiration † 1      
# participants affected / at risk     2/581 (0.34%)     2/580 (0.34%)     0/574 (0.00%)  
# events     2     2     0  
Pneumothorax Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Pulmonary Artery Stenosis † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Pulmonary Oedema Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Respiratory Distress † 1      
# participants affected / at risk     0/581 (0.00%)     4/580 (0.69%)     3/574 (0.52%)  
# events     0     5     3  
Respiratory Failure † 1      
# participants affected / at risk     1/581 (0.17%)     2/580 (0.34%)     1/574 (0.17%)  
# events     1     2     1  
Tachypnoea † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     2     0     0  
Skin and subcutaneous tissue disorders        
Face Oedema † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Urticaria Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Social circumstances        
Exposure To Communicable Disease † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Social Problem Nos † 1      
# participants affected / at risk     12/581 (2.07%)     14/580 (2.41%)     24/574 (4.18%)  
# events     12     14     24  
Surgical and medical procedures        
Cardiac Operation Nos † 1      
# participants affected / at risk     0/581 (0.00%)     1/580 (0.17%)     0/574 (0.00%)  
# events     0     1     0  
Eye Excision † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Vascular disorders        
Hypertension Nos † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Shock † 1      
# participants affected / at risk     0/581 (0.00%)     0/580 (0.00%)     1/574 (0.17%)  
# events     0     0     1  
Vasculitis Nos † 1      
# participants affected / at risk     1/581 (0.17%)     0/580 (0.00%)     0/574 (0.00%)  
# events     1     0     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 6.0




  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Margaret Camarca, Project Director
Organization: Westat
phone: 301-517-4128
e-mail: margaretcamarca@westat.com


Publications of Results:

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00099359     History of Changes
Other Study ID Numbers: NICHD/HPTN 040 (P1043)
Study First Received: December 10, 2004
Results First Received: April 25, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration