We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00016718
First Posted: August 31, 2001
Last Update Posted: October 17, 2017
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.
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)
Results First Submitted: August 1, 2017  
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)

  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
No text entered.

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
Age Group 1 90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
Age Group 2 3 years to 12 years of age, inclusive (FTC, EFV, ddI)
Age Group 3 13 years to 21 years of age, inclusive (FTC, EFV, ddI)

Participant Flow:   Overall Study
    Age Group 1   Age Group 2   Age Group 3
STARTED   6   21   16 
COMPLETED   6   21   16 
NOT COMPLETED   0   0   0 



  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
Age Group 1 90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
Age Group 2 3 years to 12 years of age, inclusive (FTC, EFV, ddI)
Age Group 3 13 years to 21 years of age, inclusive (FTC, EFV, ddI)
Total Total of all reporting groups

Baseline Measures
   Age Group 1   Age Group 2   Age Group 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   21   16   43 
Age 
[Units: Years]
Median (Full Range)
 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.   [ 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 ]

2.  Primary:   Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16   [ Time Frame: At week 16 ]

3.  Primary:   Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16   [ Time Frame: At week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
phone: (919) 405-1429
e-mail: mallen@fhi360.org


Publications of Results:
Other Publications:

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