HIV InfectionsPhase 2NCT00022763

T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

A Phase 2 study testing Enfuvirtide in people with HIV Infections, run by Hoffmann-La Roche at 7 sites in United States.

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

This study will evaluate T-20 in children. Read more about this study

Who is it for?: Ages 3 to 16 years
Conditions the study is for: HIV Infections
What is being tested?: Enfuvirtide
How many people: 52 participants
Where: 7 sitesUnited States
Study dates: Aug 2001to Dec 2004
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients may be eligible for this study if they:
Are 3 through 16 years of age and have the consent of parent or guardian.
Have a viral load of at least 5000 copies/ml.
Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
Have been on stable therapy for at least 4 weeks.

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Univ of Florida Gainesville
Gainesville, Florida, 32610
Children's Hosp Los Angeles
Los Angeles, California, 90027
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, 10021
Mount Sinai Hosp
New York, New York, 10029
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents

This study will evaluate T-20 in children.

Read the detailed description

Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.

Conditions: HIV Infections
Being tested: Enfuvirtide
Keywords: Anti-HIV Agents, pentafuside
Medical subject headings: HIV Infections

What participants receive

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

EnfuvirtideDrug

What is being measured

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

Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
Measured: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Secondary outcomes (9)

Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
Measured: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.
Measured: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)
The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated.
Measured: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Number of Participants With Adverse Events (AEs) and Serious AEs
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.
Measured: Up to Week 4 after discontinuation of therapy
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities
Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively.
Measured: Up to Week 96
Number of Participants Who Died
Measured: Up to Week 96
Number of Participants Who Prematurely Withdrew Due to AE
Measured: Up to Week 96
Number of Participants With Worst Local Injection Site Reactions
Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded.
Measured: Up to Week 96

Timeline

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

Aug 2001Dec 2004

First posted31 Aug 2001 (estimated)
Study startAug 2001
Primary completionDec 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00022763
Sponsor's protocol ID: NV16056
Other IDs: T20-310, 295E
Status last verified: Jan 2016
First submitted: 11 Aug 2001
Last updated: 15 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents
ClinicalTrials.gov ID: NCT00022763
Acronym / sponsor ID: NV16056
Conditions: HIV Infections
Keywords: Anti-HIV Agents, pentafuside
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Collaborators: Trimeris
Study start: Aug 2001
Primary completion: Dec 2004 (actual)
First posted: 31 Aug 2001 (estimated)
Results: Posted 15 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate T-20 in children.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 3 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Are 3 through 16 years of age and have the consent of parent or guardian.
Have a viral load of at least 5000 copies/ml.
Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
Have been on stable therapy for at least 4 weeks.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enfuvirtide	Drug	–

Primary outcome

Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.

9 secondary outcomes

Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Number of Participants With Adverse Events (AEs) and Serious AEs
Time frame: Up to Week 4 after discontinuation of therapy
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities
Time frame: Up to Week 96
Number of Participants Who Died
Time frame: Up to Week 96
Number of Participants Who Prematurely Withdrew Due to AE
Time frame: Up to Week 96
Number of Participants With Worst Local Injection Site Reactions
Time frame: Up to Week 96

Results and safety

Results posted to the registry on 15 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stratum A	24	15
Stratum B	28	11

Primary outcome: Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)

Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1). Mean (Standard Deviation). Unit: microgram hour per milliliter (mcg.h/mL)

Measure	Stratum A n = 12	Stratum B n = 13
Enfuvirtide	56.1 (19.4)	52.7 (27.4)
Metabolite (Ro 50-6343)	3.07 (2.77)	3.41 (2.09)

Population analysed: Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 96. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enfuvirtide	31 of 52 (59.6%)	52 of 52 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enfuvirtide in people with HIV Infections, run by Hoffmann-La Roche at 7 sites in United States.

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 5 inclusion and 0 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) (time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)). 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 NCT00022763.

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 15 Feb 2016.