Completed

141W94 with Current Nucleoside Therapy for Protease-Naive, HIV-Infected Children

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Amprenavir

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 6 Months to 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children < 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.

NCT00002193
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

210 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

7 inclusion criteria required to participate
Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study
Has a negative pregnancy test within 7 days of study entry
Has a viral load (level of HIV in the body) greater than 10,000 copies/ml
Has consent of parent or legal guardian if under 18
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7 exclusion criteria prevent from participating
Has a serious illness, including any life-threatening infection or other chronic serious medical condition
Has an opportunistic (AIDS-related) infection or a serious bacterial infection
Has received certain medications
Has received radiation therapy within the past 4 months, or will need to receive it during the study
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Children's Diagnostic Treatment Ctr

Fort Lauderdale, United StatesOpen Children's Diagnostic Treatment Ctr in Google Maps

Saint Jude Children's Hosp / Dept of Infect Diseases

Memphis, United States
Completed2 Study Centers