Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine - Full Text View

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00743340

Purpose

The purpose of this study is to provide current FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine, following completion of the FTC-203 study. Subjects participating in this rollover protocol will receive emtricitabine, for as long as they continue to meet specific virologic criteria and until they withdraw from study or emtricitabine is approved in the country of residence.

Condition	Intervention	Phase
HIV-1 Infection	Drug: FTC	Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

There is no primary outcome measure. Only SAEs, AEs leading to discontinuation of the study drug, emtricitabine, regardless of seriousness/severity and AEs associated with skin discoloration (hyperpigmentation) will be collected [ Time Frame: 720 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	49
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2020 (Final data collection date for primary outcome measure)

Intervention Details:

FTC capsule 200mg qd

FTC Oral Solution 6mg/kg qd

Detailed Description:

In addition to access to emtricitabine, the study will collect long-term safety information in subjects receiving emtricitabine in combination with other antiretroviral agents. Data collection during the rollover protocol for safety purposes will be limited to the reporting of adverse events (AEs) that (1) meet the criteria for a serious adverse event (SAE), (2) result in permanent discontinuation of the study drug, emtricitabine, and/or (3) are associated with skin discoloration (hyperpigmentation).

Eligibility

Ages Eligible for Study:	1 Month to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Complete or have previously completed at least through the Week 96 Visit (i.e., 96 weeks on study) for the FTC-203 study.
Complete all End-of-Study Visit procedures for the FTC-203 study.
Either (a) have a plasma HIV-1 RNA viral load of ≤ 400 copies/mL at the End-of-Study Visit for the FTC-203 study, or (b) if the subject's plasma HIV-1 RNA viral load at the End-of-Study Visit for FTC-203 study is > 400 copies/mL, their viral load is < 1.0 log10 above the nadir recorded after Week 8 of the FTC-203 study and there is reliable genotypic evidence showing a lack of resistance to emtricitabine.
A parent or other legal guardian has provided written informed consent to the subject participating in the rollover protocol. As applicable, based on the subject's age and normal institution practice, the subject should additionally provide their written informed consent or assent to participate in the rollover protocol.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743340

Locations

South Africa
Themba Lethu Clinic, Helen Joseph Hospital, Westdene
Johannesburg, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Soweto, South Africa

Sponsors and Collaborators

Gilead Sciences

More Information

Responsible Party:	Gilead Sciences, Inc. ( Elsa Mondou, MD )
Study ID Numbers:	GS-US-162-0112
Study First Received:	August 26, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00743340
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

HIV-1 infection
emtricitabine
pediatrics
pediatric patients

Study placed in the following topic categories:

Emtricitabine
HIV Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009