Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
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Tracking Information | |||||
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First Received Date ICMJE | July 13, 2006 | ||||
Last Updated Date | June 15, 2012 | ||||
Start Date ICMJE | July 2006 | ||||
Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: No ] DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value. |
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Original Primary Outcome Measures ICMJE |
Time averaged change in HIV RNA at week 24 | ||||
Change History | Complete list of historical versions of study NCT00352053 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy | ||||
Official Title ICMJE | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Tenofovir DF as Part of an Optimized Antiretroviral Regimen in HIV-1-Infected Adolescents | ||||
Brief Summary | The purpose of this study was to assess the safety and efficacy of tenofovir disoproxil fumarate (TDF) plus a genotype-guided optimized background regimen (OBR) compared to placebo plus OBR in the treatment of human immunodeficiency virus type 1 (HIV-1) infected antiretroviral treatment-experienced adolescents with plasma HIV-1 ribonucleic acid (RNA) levels greater than or equal to 1000 copies/mL. |
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Detailed Description | This was a 48-week, randomized, double-blind, placebo-controlled, multicenter study of the safety and efficacy of tenofovir DF as part of an optimized antiretroviral regimen in HIV-1 infected adolescents (12 years to < 18 years of age) who were failing their current antiretroviral regimen and had HIV-1 RNA levels >= 1000 copies/mL at screening. Data from three consecutive 96-week study extensions (ongoing) have been used to evaluate the long-term efficacy, safety, and tolerability of open-label tenofovir DF as part of an antiviral regimen, providing data for up to 336 weeks of total drug exposure. Pretreatment: HIV-1 genotyping was performed as part of the screening assessments to assist in the construction of an OBR, defined as at least 3, but no more than 5 antiretroviral agents, not including tenofovir DF or placebo. Randomized Phase: Participants were randomized in a 1:1 ratio to receive either tenofovir DF + OBR or placebo + OBR. The majority of efficacy and safety assessments were performed at each clinic visit (Weeks 4, 8, 16, 24, 32, 40, and 48). At Week 24, participants who were adherent to study drug (in the opinion of the investigator), but did not demonstrate a >= 0.5 log10 copies/mL decrease from baseline in HIV-1 RNA, were considered to be nonresponders and were unblinded. Nonresponders randomized to the placebo group were given the option to continue on study and receive open-label tenofovir DF with an appropriate background regimen determined by the investigator. Nonresponders randomized to the tenofovir DF treatment group were discontinued from the study. Extension Phases: After completing 48 weeks of double-blind treatment with tenofovir DF or placebo, participants who had not reached 18 years of age, and who, in the opinion of the investigator, would derive clinical benefit from the use of open-label tenofovir DF, were given the option to continue (or initiate) treatment with open-label tenofovir DF in the first of three 96 week study extension periods. Nonresponders who received open-label tenofovir DF after Week 24 were also considered eligible for the first study extension if they met the above criteria at Week 48. After completing the first 96 week study extension, participants who had not reached 18 years of age, and who had shown ongoing clinical benefit from tenofovir DF, were given the option to continue receiving open-label tenofovir DF for an additional 96 weeks or until tenofovir DF became commercially available in the country where the participants were enrolled, whichever occurred first. After completing the second 96 week study extension, participants who had not reached 18 years of age, and who had shown ongoing clinical benefit from tenofovir DF, were given the option to continue receiving open-label tenofovir DF for an additional 96 weeks or until tenofovir DF became commercially available in the country where the participants were enrolled, whichever occurred first. Presentation of data: Participants who were randomized to placebo during the randomized phase of the study and then switched to open-label tenofovir DF had their baseline reset (defined as open-label baseline), and only outcome data collected after (on/after for AEs/concomitant medications) participants received their first dose of open-label tenofovir DF were included in this entry. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 87 | ||||
Estimated Completion Date | April 2013 | ||||
Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Major Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 12 Years to 17 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Brazil, Panama | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352053 | ||||
Other Study ID Numbers ICMJE | GS-US-104-0321 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Gilead Sciences | ||||
Study Sponsor ICMJE | Gilead Sciences | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Gilead Sciences | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |