An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects

NCT00642291 | Completed Phase 2

• 1 other identifier: FTC-211
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1 infected pediatric subjects and, if necessary, to refine the dose of emtricitabine to achieve concentrations comparable to those in adults given 200 mg emtricitabine once-daily.

Conditions

HIV Infections

Keywords

Emtricitabine; Pediatric; HIV-1; Treatment of HIV-1

Outcome Measures

Primary Outcomes (2)

• The primary safety endpoint was tolerability failure (A patient was classified as a tolerability failure if (s)he had any adverse event or laboratory toxicity that lead to the permanent discontinuation of emtricitabine

  Week 48

• The primary efficacy endpoint was defined as the suppression of plasma HIV-1 RNA levels below 50 copies/mL at Week 48

  Week 48

Secondary Outcomes (7)

• Time to loss of virological response (TLOVR)

  Week 48

• plasma HIV-1 RNA change from baseline

  Week 48

• proportion of patients with plasma HIV-1 RNA below 400 copies/mL

  Week 48

• CD4+ change from baseline by study visit

  Week 48

• Proportion of virologic failures

  Week 48

Study Arms (2)

1

EXPERIMENTAL

Treatment naive pediatric patients (Group 1: ages 3 to 24 months)were to receive emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if \<30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if \>=7 to \<15kg; 10/2.5 mg/kg BID if \>=15 to \<=40 kg)

Drug: Emtricitabine

2

EXPERIMENTAL

Treatment naive or experienced pediatric patients (Group 2: ages 7 to 12 years; Group 3: ages 13-17 years) received emtricitabine (6 mg/kg QD, up to 200 mg QD capsule formulation or up to 240 mg QD using the oral solution) plus didanosine (240 mg/m2 up to 400 mg QD) plus efavirenz (up to 600 mg QD capsule formulation or up to 720 mg QD using the oral solution).

Drug: Emtricitabine

Interventions

Emtricitabine DRUG

emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if \<30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if \>=7 to \<15kg; 10/2.5 mg/kg BID if \>=15 to \<=40 kg)

Also known as: FTC

1

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, aged from 3 to 24 months old or from 7 to 17 years old. (Note: This criterion was based on the subject's age at Baseline \[Day 1\].)
• Documented evidence of HIV-1 infection. (Note: HIV-1 infection had to be confirmed by two positive results obtained in any of the following:
• at any age: HIV culture, HIV DNA PCR, or plasma HIV RNA of \>= 10,000 copies/mL;
• age \> 4 weeks: neutralizable HIV p24 antigen; or
• age \> 18 months: licensed ELISA with confirmatory Western blot.)
• Body weight \> 2.5 kg (\>5.5 lb).
• Either ART-naïve or ART-experienced, as defined below:
• ART-naïve: no prior exposure to any ART (with the exception of \<= 56 cumulative days of perinatal prophylactic treatment for the prevention of maternal-to-child transmission or \<=6 weeks of cumulative postnatal treatment with ZDV monotherapy) and a Screening plasma HIV-1 RNA level of \>= 5,000 copies/mL and, in children aged \>= 7 years old, a plasma HIV-1 RNA of \<= 600,000 copies/mL.
• ART-experienced: no previous treatment with an ART regimen(s) that included either lamivudine and/or an NNRTI and a Screening plasma HIV-1 RNA level of \<= 600,000 copies/mL.
• Absolute CD4+ cell count of \>= 200 cells/mm3.
• Subjects whose parent or other legal guardian provided written informed consent to participate in the study.
• Female subjects of childbearing potential (i.e., post-pubertal) with a negative serum beta human chorionic gonadotropin (Beta-HCG) test at Screening that was confirmed by a negative urine pregnancy test at Baseline, prior to administration of the first dose of emtricitabine.
• If sexually active and/or of childbearing potential, the subject (male and female) had to be willing to use an effective method of contraception while enrolled in the study and for a period of at least 1 month after the last dose of emtricitabine

You may not qualify if:

• Either the subject or the subject's parent or other legal guardian was unable to adhere to the child's dosing schedule and protocol evaluations.
• Female subjects who were pregnant or who were breastfeeding.
• Treatment within 30 days prior to Baseline with an investigational drug, agent, and/or vaccine (with the exception of investigational formulations of approved drugs) unless prior approved by both the investigator and sponsor.
• Subjects who required the concomitant use of: (a) immunomodulators (with the exception of immune globulin and colony stimulating factors); (b) investigational drug,agent, and/or vaccines (with the exception of investigational formulations of approved drugs; and/or (c) any medication that was contra-indicated for any protocol-prescribed background medication, unless pre-approved by both the investigator and sponsor.
• Subjects with any of the following laboratory parameters at Screening:
• Hemoglobin \>= Grade 3 toxicity;
• Absolute neutrophil count ≥ Grade 2 toxicity (assessed without Neupogen \[filgrastim, G-CSF\]);
• Platelet count \>= Grade 2 toxicity;
• Serum creatinine \>= Grade 2 toxicity;
• Total bilirubin \>= Grade 2 toxicity (other than for Gilbert's syndrome); and
• Subjects with any other clinical or laboratory abnormality of \>= Grade 3 toxicity (using age-specific toxicity grading scales for children \< 13 years old and \>= 13 years old at Screening unless pre-approved by the investigator and sponsor.
• Subjects with \>= Grade 2 peripheral neuropathy at Screening or with a significant history of peripheral neuropathy.
• Subjects with malabsorption or severe chronic diarrhea (\>= Grade 2) within 30 days before Screening, or subjects who were unable to consume adequate oral intake (defined as the inability to eat \>= 1 meal(s) a day or to have 3 feedings a day for young infants) because of chronic nausea, emesis, or abdominal or esophageal discomfort.
• Subjects with an acute and serious medical event within 30 days prior to Screening unless pre-approved by the investigator and sponsor. (Note: Acute treatment must have been completed for \>= 14 days prior to Baseline.)
• Subjects with an AIDS-defining opportunistic infection within 12 months prior to Screening.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (2)

Unknown Facility

Bucharest, Sector 2, Romania

Location

Unknown Facility

Bucharest, Sector 3, Romania

Location

Related Links

• Related Info
• Study Results

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine

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)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 25, 2008
• Study Start: November 1, 2002
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: April 10, 2008

Record last verified: 2008-04

Locations

RO (2)