Phase 2 Completed N=138 Treatment

A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years

HIV

Source: ClinicalTrials.gov NCT00040664 ↗

Enrolled (actual)

138

Serious AEs

—

Results posted

Feb 2010

Primary outcomePrimary: Number of Participants Who Discontinued Treatment Due to Adverse Events — 12; 3; 3; 1 Participants

Summary

This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Discontinued Treatment Due to Adverse Events	12; 3; 3; 1; 1; 1	—
PRIMARY Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event	7; 14; 0; 5; 2; 1	—
PRIMARY Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities	6; 2; 3; 0; 0; 0	—
PRIMARY Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)	47.3; 47.6; 75.5; 71.8	—
PRIMARY Geometric Mean of Steady State Plasma APV Parameter: Cmax	4.97; 5.07; 6.88; 7.70	—
PRIMARY Median Steady State Plasma APV Tmax	1.04; 1.12; 1.08; 3.78	—
PRIMARY Geometric Mean of Steady State Plasma APV Parameter: CL/F	278	—
PRIMARY Geometric Mean of Steady State Plasma APV Parameter: t1/2	17.5; 13.6; 15.0; 14.9	—
PRIMARY Least Squares Mean of Plasma APV Parameter: AUC0-tau	0.695; 0.699; 1.11; 1.06	—
PRIMARY Least Squares Mean of Plasma APV Parameter: Cmax	0.663; 0.676; 0.917; 1.03	—
PRIMARY Least Squares Mean of Plasma APV Parameter: Ctau	0.716; 0.837; 0.963; 0.706	—
SECONDARY Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)	22; 20; 16; 16; 13; 11	—
SECONDARY Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits	-2.85; -2.03; -2.65; -1.65; -2.52; -1.76	—
SECONDARY Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits	95; 40; 150; 120; 160; 40	—
SECONDARY Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline	2; 2	—

Eligibility Criteria

Inclusion Criteria:
Male or females 2 to 18 years of age
A female is eligible to enter and participate in this study if she is of:
a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial); or,
b. child-bearing potential with a negative serum pregnancy test at screen, a negative urine pregnancy test on Day 1 and who agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the product label and the instructions of a physician). Note: hormonal contraceptives are not considered a sufficient form of contraceptive for this study.
Complete abstinence from intercourse from 2 weeks prior to administration of study drugs, throughout the study and for 2 weeks after discontinuation of all study medications. Should a female subject of childbearing potential decide to become sexually active during the course of the study, she must be counselled and be willing to use one of the methods listed below:
Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion)
Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year. All subjects participating in this study should be counselled on the practice of safe/safer sex.
Parent or legal guardian (and subject whenever possible) has the ability to understand and provide written informed consent for the subject to participate in the trial. Verbal witnessed assent must be obtained from the subject whenever possible.
Screening plasma HIV-1 RNA > or =400copies/mL.
Subject's who, in the investigator's opinion, and following resistance testing where appropriate, are able to construct an active NRTI backbone regimen consisting of 2 NRTIs.
Subjects must meet one of the following criteria:
ART-naïve subjects are defined as having had < 4 weeks (28 days) therapy with an NRTI, no previous therapy with an NNRTI and < 1 week therapy with an HIV PI.
ART-experienced subjects are defined as having had greater than 4 weeks (28 days) therapy with any NRTI(s) and any length of therapy with any NNRTI(s) and/or a PI. PI-experienced subjects will be eligible if they have previously been treated with < three PIs, excluding AGENERASE. Prior therapy with a RTV boosted PI regimen will be considered as only 1 prior PI as long as the RTV dose was below that recommended for use of RTV as an antiretroviral agent. This specific criterion is not applicable to subjects in screening and/or enrolling after approval of Amendment No. 4. - For subjects screening and/or enrolling after the approval of Amendment No.4, PI naive subjects are defined as ART experienced subjects having less than one week of therapy with a PI and no prior experience with AGENERASE. Prior treatment with NNRTIs and NRTIs is permitted (however, subjects will NOT be permitted to receive concurrent NNRTI therapy while participating in this study)
Exclusion Criteria:
Prior history of having received amprenavir.
Use of non-nucleoside reverse transcriptase inhibitor (NNRTI) therapy within 14 days of study Day 1 or anticipated need for concurrent NNRTI therapy during the study period.
Have had an AIDS defining illness (acute CDC Category C event) within 28 days of screening.
Pregnant or lactating.
Non-nucleoside reverse transcriptase inhibitor therapy within 14 days prior to study drug administration or anticipated need for concurrent NNRTI therapy during the study period.
Subjects who, in the investigator's opinion, are not able to comply with the requirements of the study.
An acute CDC Category C event (per 1993/1994 classification) and/or serious bacterial infection(s) within 28 days prior to study drug adm

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Data sourced from ClinicalTrials.gov (NCT00040664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.