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HIV InfectionsPhase 2NCT00642291

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

A Phase 2 study testing Emtricitabine in people with HIV Infections, run by Gilead Sciences at 2 sites in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 months to 17 years
Conditions the study is for
HIV Infections
What is being tested?
Emtricitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesRomania
Study dates
Nov 2002to Jul 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).
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  • 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.
  • OR
  • 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

Who cannot join

  • 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;
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  • Absolute neutrophil count ≥ Grade 2 toxicity (assessed without Neupogen [filgrastim, G-CSF]);
  • Platelet count >= Grade 2 toxicity;
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= Grade 2 toxicity;(Note: Re-screening was NOT allowed for an exclusionary AST or ALT value, unless acute viral hepatitis was documented and the elevated ALT and/or AST demonstrated complete resolution with no exclusionary amylase or lipase value.)
  • Serum creatinine >= Grade 2 toxicity;
  • Total bilirubin >= Grade 2 toxicity (other than for Gilbert's syndrome); and
  • Pancreatic amylase or total amylase plus lipase >= Grade 2 toxicity. (Note: Re-screening was NOT allowed for exclusionary amylase or lipase values.)
  • 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.
  • Life expectancy < 12 months.
  • Subjects currently being treated for active tuberculosis.
  • Subjects with a history of acute or chronic (clinical or biological) pancreatitis (regardless of their serum amylase levels).
  • Any other condition or set of circumstances, which, in the opinion of the investigator or sponsor, could have interfered with the subject's ability to comply with the dosing schedule and complete the study evaluations.

Trial locations and contacts

2 sites in 1 country.

Romania2 sites

  • Study site

    Bucharest, Sector 2

  • Study site

    Bucharest, Sector 3

Other trials in Romania

About this study

Official title: An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects

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
Being tested
Emtricitabine
Keywords
Emtricitabine, Pediatric, HIV-1, Treatment of HIV-1
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmtricitabineDrug

    Also called FTC

    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)

  • EmtricitabineDrug

    Also called FTC

    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).

Study groups in NCT00642291
Study groupRoleWhat they receive
1ExperimentalTreatment 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)
Receives: Drug: Emtricitabine
2ExperimentalTreatment 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).
Receives: Drug: Emtricitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 48

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

    Measured: Week 48

Secondary outcomes (7)

  1. Time to loss of virological response (TLOVR)

    Measured: Week 48

  2. plasma HIV-1 RNA change from baseline

    Measured: Week 48

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

    Measured: Week 48

  4. CD4+ change from baseline by study visit

    Measured: Week 48

  5. Proportion of virologic failures

    Measured: Week 48

  6. Incidence of adverse events, laboratory toxicities, and treatment discontinuations

    Measured: Week 48

  7. PK parameters: steady state (0-24hr) plasma AUC for emtricitabine; emtricitabine plasma trough concentration

    Measured: Week 2 and between Weeks 8 to 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2008 (estimated)
  2. Study startNov 2002
  3. Primary completionJul 2004
  4. Study completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00642291
Sponsor's protocol ID
FTC-211
Status last verified
Apr 2008
First submitted
19 Mar 2008
Last updated
10 Apr 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Emtricitabine in people with HIV Infections, run by Gilead Sciences at 2 sites in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00642291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.

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