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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:
National Institute of Allergy and Infectious Diseases (NIAID)
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)
ClinicalTrials.gov Identifier:
NCT00016718
First received: May 31, 2001
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study is to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who have taken few or no anti-HIV drugs.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Didanosine Drug: Efavirenz Drug: Emtricitabine | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Development of Grade 3 or 4 adverse events attributed to the study treatment [ Time Frame: Throughout study ]
- Suppression of HIV viral load to less than 400 copies/ml and 50 copies/ml at Week 16 [ Time Frame: Throughout study ]
- Time to virologic failure at or after Week 16 [ Time Frame: Throughout study after Week 16 ]
| Enrollment: | 43 |
| Study Start Date: | August 2001 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
All patients will receive ddI, EFV, and FTC together once daily. Study visits will occur at study entry, Weeks 2 and 4, and every 4 weeks thereafter.
|
Drug: Didanosine
Antiretroviral
Drug: Efavirenz
Antiretroviral
Drug: Emtricitabine
Antiretroviral
|
Detailed Description:
Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents. Few PIs are available in formulations appropriate for pediatric patients, and complex dosing schedules and food requirements may be detrimental to treatment adherence. A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor (NNRTI) EFV has been shown safe and well tolerated in adults. This study will evaluate the long-term safety and efficacy of a ddI, FTC, and EFV regimen in pediatric patients.
Patients will be followed for a maximum of 192 weeks; all patients will receive ddI, EFV, and FTC together once daily. Study visits will occur at study entry, Weeks 2 and 4, and every 4 weeks thereafter. Blood collection, medical history assessment, and a physical exam will occur at all visits; urine collection will occur at selected visits. Intensive pharmacokinetic (PK) studies will be done at Weeks 2 and 12 to determine if dose adjustments are required for any of the drugs. If virologic failure is determined, PK studies will be repeated 4 weeks after adjustments in therapy. Parents or guardians will be asked to complete treatment adherence questionnaires at some visits. Some patients may also be asked to participate in an additional PK study after Week 16 or week 96.
Eligibility| Ages Eligible for Study: | 90 Days to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV infected
- Antiretroviral naive OR have received no more than 56 days of drugs to prevent mother-to-child transmission of HIV OR have received less than 7 total days of antiretroviral therapy
- Viral load of 5,000 copies/ml or more
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- Allergic to study medications or their formulations
- Kidney disease
- Positive for hepatitis B or C
- AIDS-related or other infection requiring treatment at study entry
- Taking drugs to treat tuberculosis
- Taking anti-HIV drugs other than those included in this study
- Taking any investigational drugs
- Anti-cancer drugs within 1 year of study screening
- Serious medical event within 21 days of study screening
- Active or history of pancreatitis
- Require certain medications. Patients requiring short courses of steroids (less than 14 days) for asthma are not excluded.
- Active or history of significant peripheral neuropathy
- Difficulty with food or severe chronic diarrhea within 30 days before study entry
- Unable to eat at least 1 meal per day (or to feed at least 3 times per day, for infants) because of chronic nausea, vomiting, swallowing problems, or stomach upset
- Unable to swallow oral medications
- Pregnant or breastfeeding
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016718
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016718
Locations
| United States, California | |
| UCSD Maternal, Child, and Adolescent HIV CRS | |
| San Diego, California, United States | |
| UCSF Pediatric AIDS CRS | |
| San Francisco, California, United States, 941430105 | |
| United States, Colorado | |
| Univ. of Colorado Denver NICHD CRS | |
| Aurora, Colorado, United States, 802181088 | |
| United States, District of Columbia | |
| Howard Univ. Washington DC NICHD CRS | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Univ. of Florida Jacksonville NICHD CRS | |
| Jacksonville, Florida, United States, 32209 | |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | |
| Miami, Florida, United States, 33161 | |
| United States, Illinois | |
| Chicago Children's CRS | |
| Chicago, Illinois, United States, 606143394 | |
| Rush Univ. Cook County Hosp. Chicago NICHD CRS | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| Children's Hosp. of Boston NICHD CRS | |
| Boston, Massachusetts, United States, 021155724 | |
| WNE Maternal Pediatric Adolescent AIDS CRS | |
| Worcester, Massachusetts, United States, 016550001 | |
| United States, New York | |
| Nyu Ny Nichd Crs | |
| New York, New York, United States, 10016 | |
| Harlem Hosp. Ctr. NY NICHD CRS | |
| New York, New York, United States | |
| SUNY Upstate Med. Univ., Dept. of Peds. | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| DUMC Ped. CRS | |
| Durham, North Carolina, United States, 277103499 | |
| United States, Tennessee | |
| St. Jude/UTHSC CRS | |
| Memphis, Tennessee, United States, 381052794 | |
| United States, Texas | |
| Texas Children's Hosp. CRS | |
| Houston, Texas, United States, 77030 | |
| Puerto Rico | |
| Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | |
| San Juan, Puerto Rico, 009365067 | |
| San Juan City Hosp. PR NICHD CRS | |
| San Juan, Puerto Rico, 009367344 | |
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Study Chair: | Ross E. McKinney, Jr., MD | Duke University |
| Study Chair: | Mobeen H. Rathore, MD | Pediatric Infectious Diseases/Immunology, University of Florida Health Science Center |
More Information
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 |
| Study First Received: | May 31, 2001 |
| Last Updated: | May 3, 2013 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Didanosine Drug Therapy, Combination Drug Administration Schedule Reverse Transcriptase Inhibitors Anti-HIV Agents |
Pharmacokinetics Deoxycytidine Efavirenz Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Efavirenz Emtricitabine Didanosine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Anti-HIV Agents Antimetabolites |
ClinicalTrials.gov processed this record on June 23, 2017