HIV Infections Clinical Trial
Official title:
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
The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil fumarate (tenofovir DF; 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.
This is 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 are failing their current
antiretroviral regimen and have HIV-1 RNA levels ≥ 1000 copies/mL at screening. Data from
three consecutive 96-week study extensions 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 will be 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 will be randomized in a 1:1 ratio to receive either tenofovir DF + OBR, or
placebo + OBR. The majority of efficacy and safety assessments will be performed at each
clinic visit (Weeks 4, 8, 16, 24, 32, 40, and 48). At Week 24, participants who are adherent
to study drug (in the opinion of the investigator), but do not demonstrate a ≥ 0.5 log10
copies/mL decrease from baseline in HIV-1 RNA, will be considered to be nonresponders and
will be unblinded. Nonresponders randomized to the placebo group will be 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
will be discontinued from the study.
Extension Phases:
After completing 48 weeks of double-blind treatment with tenofovir DF or placebo,
participants who have 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, will be
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 receive open-label
tenofovir DF after Week 24 will also be 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 have not reached 18
years of age, and who have shown ongoing clinical benefit from tenofovir DF, will be 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 are
enrolled, whichever occurs first.
After completing the second 96 week study extension, participants who have not reached 18
years of age, and who have shown ongoing clinical benefit from tenofovir DF, will be 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 are
enrolled, whichever occurs first.
Presentation of data:
After the randomized phase of the study, participants randomized to placebo during the
randomized phase of the study and then switch to open-label tenofovir DF will have their
baseline reset (defined as open-label baseline), and only outcome data collected after
(on/after for adverse events (AEs)/concomitant medications) participants receive their first
dose of open-label tenofovir DF will be included.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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