T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00022763|
Recruitment Status : Completed
First Posted : August 31, 2001
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Enfuvirtide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||December 2004|
- 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.
- 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) ]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.
- 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) ]Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
- 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) ]Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.
- 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) ]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.
- Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Up to Week 4 after discontinuation of therapy ]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.
- Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities [ Time Frame: Up to Week 96 ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022763
|United States, California|
|Children's Hosp Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Florida|
|Univ of Florida Gainesville|
|Gainesville, Florida, United States, 32610|
|United States, New York|
|Bronx Lebanon Hosp Ctr|
|Bronx, New York, United States, 10457|
|Bronx Municipal Hosp Ctr/Jacobi Med Ctr|
|Bronx, New York, United States, 10461|
|New York Hosp - Cornell / Program for Children with AIDS|
|New York, New York, United States, 10021|
|Mount Sinai Hosp|
|New York, New York, United States, 10029|
|United States, Virginia|
|Children's Hosp of the King's Daughters|
|Norfolk, Virginia, United States, 23507|