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

NCT00016718 | Completed Phase 1 Results

• 5 other identifiers: P102110038ACTG P1021PACTG P1021IMPAACT P1021
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 18

Brief Summary

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 was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.

Conditions

HIV Infections

Keywords

Didanosine; Drug Therapy, Combination; Drug Administration Schedule; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Pharmacokinetics; Deoxycytidine; Efavirenz; Treatment Naive

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.

  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.

  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

• Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16

  Proportion was calculated as number of participants with HIV-1 RNA \<= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.

  At week 16

• Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16

  Proportion was calculated as number of participants with HIV-1 RNA \<= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.

  At week 16

Study Arms (3)

Age Group 1: 90 days to < 3 years of age (FTC, EFV, ddI)

EXPERIMENTAL

Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily

Drug: Didanosine (ddI); Drug: Efavirenz (EFV); Drug: Emtricitabine (FTC)

Age Group 2: 3 to 12 years of age (FTC, EFV, ddI)

EXPERIMENTAL

Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily

Drug: Didanosine (ddI); Drug: Efavirenz (EFV); Drug: Emtricitabine (FTC)

Age Group 2: 13 to 21 years of age (FTC, EFV, ddI)

EXPERIMENTAL

Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily

Drug: Didanosine (ddI); Drug: Efavirenz (EFV); Drug: Emtricitabine (FTC)

Interventions

Didanosine (ddI) DRUG

Antiretroviral Didanosine (ddI) : 240 mg/m\^2 up to a maximum of 400 mg once daily

Also known as: Videx, Videx EC

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

Efavirenz (EFV) DRUG

Antiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution

Also known as: Sustiva

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

Emtricitabine (FTC) DRUG

Antiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily

Also known as: Emtriva

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

Eligibility Criteria

• Age: 90 Days - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Any Center for Disease Control (CDC) classification and immune status
• Able to swallow study medications
• Parent or guardian willing to provide informed consent, if applicable
• Willing to use acceptable forms of contraception
• female subjects of childbearing potential with a negative serum beta human chronic gonadotropin

You may not qualify if:

• Allergic to study medications or their formulations
• Kidney disease
• Positive for hepatitis B or C
• Acute opportunistic infection (OI) or bacterial infection requiring treatment at study entry
• Taking drugs to treat tuberculosis
• Taking anti-HIV drugs other than those included in this study
• Hemoglobin \>= grade 3 at screening
• Absolute Neutrophil counts \>= grade 2 at screening
• Platelets \>= Grade 2 at screening
• Bilirubin \>= Grade 2 at screening
• SGOT (AST), SGPT(ALT) \>= Grade 2 at screening
• Non-fasting triglycerides \>= Grade 2 at screening. Confirmed by a 2nd determination \>=100 mg/dl at fasting state
• Pancreatic amylase or total amylase+ lipase \>= Grade 2 at screening
• Taking any investigational drugs
• Anti-cancer drugs within 1 year of study screening

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (18)

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, 941430105, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 802181088, United States

Location

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

Chicago Children's CRS

Chicago, Illinois, 606143394, United States

Location

Rush Univ. Cook County Hosp. Chicago NICHD CRS

Chicago, Illinois, United States

Location

Children's Hosp. of Boston NICHD CRS

Boston, Massachusetts, 021155724, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, 016550001, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 277103499, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 381052794, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 009365067, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 009367344, Puerto Rico

Location

Related Publications (2)

• McKinney RE Jr, Cunningham CK. Newer treatments for HIV in children. Curr Opin Pediatr. 2004 Feb;16(1):76-9. doi: 10.1097/00008480-200402000-00014.

  PMID: 14758118 BACKGROUND

• Weinberg A, Dickover R, Britto P, Hu C, Patterson-Bartlett J, Kraimer J, Gutzman H, Shearer WT, Rathore M, McKinney R; PACTG 1021 team. Continuous improvement in the immune system of HIV-infected children on prolonged antiretroviral therapy. AIDS. 2008 Nov 12;22(17):2267-77. doi: 10.1097/QAD.0b013e3283189bb3.

  PMID: 18981766 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Didanosine; efavirenz; Emtricitabine; Racivir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Melissa Allen, Director, IMPAACT Operations Center
• Organization: Family Health International (FHI 360)

mallen@fhi360.org

(919) 405-1429

Study Officials

• Ross E. McKinney, Jr., MD

  Duke University

  STUDY CHAIR

• Mobeen H. Rathore, MD

  Pediatric Infectious Diseases/Immunology, University of Florida Health Science Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2001
• First Posted: August 31, 2001
• Study Start: August 1, 2001
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 5, 2021
• Results First Posted: October 17, 2017

Record last verified: 2017-09

Locations

PR (2); US (16)