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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Amprenavir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Diagnostic Treatment Ctr
Saint Jude Children's Hosp / Dept of Infect Diseases

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002193

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Glaxo Wellcome

1. Study Identification

Unique Protocol Identification Number

NCT00002193

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 1999

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Glaxo Wellcome

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Enrollment

210 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amprenavir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Facility Information:

Facility Name

Children's Diagnostic Treatment Ctr

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33301

Country

United States

Facility Name

Saint Jude Children's Hosp / Dept of Infect Diseases

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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