Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of 141W94 Plus Current Nucleoside Therapy Versus Current Nucleoside Therapy Alone in Protease-Naive, HIV-Infected Children
Brief Summary	The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).
Detailed Description	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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Parallel Assignment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Amprenavir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	210
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Your child may be eligible for this study if he/she: Is 6 months - 18 years of age. Is HIV-positive. Has a viral load (level of HIV in the body) greater than 10,000 copies/ml. Is able to take medications by mouth. Has consent of parent or legal guardian if under 18. Has a negative pregnancy test within 7 days of study entry. Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study. Exclusion Criteria Your child will not be eligible for this study if he/she: 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. Is allergic to NRTIs. Is breast-feeding. Is unlikely to complete the study. Has received certain medications. Has received radiation therapy within the past 4 months, or will need to receive it during the study.
Gender	Both
Ages	6 Months to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002193
Responsible Party
Study ID Numbers ^ICMJE	264C, PROA3004
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP