Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Su… (NCT00071760) | Clinical Trial Compass
CompletedPhase 2
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
United States, Argentina, Mexico59 participantsStarted 2003-10-23
Plain-language summary
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \< 2 years old.
Who can participate
Age range
4 Weeks – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female 4 weeks to \<2 years of age. Cohort 1 (6 months - \<2 years): Subjects must be \<2 years of age at the Week 2 visit therefore the maximum age at screening is 22 months.
Cohort 2 (4 weeks - \<6 months): Subjects must be \<6 months of age at the Week 2 visit, therefore the maximum age at screening is 4 months for entry into this cohort.
* Parent or legal guardian is willing and able to provide written informed consent for the subject to participate in the trial.
* Screening plasma HIV-1 RNA level \>=400copies/mL.
* Subjects who, in the investigator's opinion, and following viral resistance testing if conducted, are able to construct an active Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone regimen consisting of 2 NRTIs.
* Subjects must meet one of the following criteria:
Therapy-naïve or PI-naïve subjects (defined as having received less than one week of any PI).
PI-experienced subjects defined as having prior experience with no more than three PIs. Prior RTV-boosted PI therapy will be considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
Exclusion Criteria:
* Prior history of having received APV.
* Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) therapy within 14 days prior to study drug administration (single or multiple dose) or anticipated need for concurrent NNRTI therapy during the study period.
* PI therapy within 5 days prior to study drug…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Amprenavir (APV) AUC (0-tau[τ])
Timeframe: Week 48
2
Plasma APV Cmax
Timeframe: Week 48
3
Plasma APV Cτ
Timeframe: Week 48
4
Plasma APV CL/F Following Dosing Expressed in mL/Min/kg
Timeframe: Week 48
5
Plasma APV CL/F Following Dosing Expressed in mL/Min
Timeframe: Week 48
6
Plasma Unbound APV Cτ
Timeframe: Week 48
7
Plasma Unbound APV Percent Protein Binding (%Cτ)
Timeframe: Week 48
8
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48
Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48
9
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48
Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48
10
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48
Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, and 48
11
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities
Timeframe: Baseline (Day 1) until Week 48
12
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)
Timeframe: Baseline (Day 1) until Week 48
13
Number of Participants Who Permanently Discontinued the Treatment Due to an AE