HIV InfectionsPhase 3NCT00352053
Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
A Phase 3 study testing Tenofovir DF in people with HIV Infections, run by Gilead Sciences at 18 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir DF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jun 2006to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Patients requiring didanosine in background regimen
- Prior history of significant renal disease
- Prior history of significant bone disease
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Brazil17 sites
Faculdade de Medicina - UFMG
Belo Horizonte - MG
Santa Casa de Belo Horizonte
Belo Horizonte - MG
Hospital e Maternidade Celso Pierro
Campinas - SP
Universidade Estadual de Campinas - UNICAMP
Campinas - SP
Centro de Doenças Infecciosas e Parasitárias
Campo Grande - MS
Hospital das Clinicas da Universidade Federal do Parana - UFPR
Curitiba - PR
Hospital Infantil Joana de Gusmão
Florianópolis - SC
Hospital Municipal Sao Jose
Joinville - SC
Hospital Materno Infantil Professor Fernando Figueira- IMIP
Recife
Hospital dos Servidores do Estado
Rio de Janeiro
Hospital Geral de Nova Iguacu Ambulatorio de DST e AIDS
Rio de Jeneiro
Hospital Guilherme Alvaro
Santos
NEIMPE - Dept of Pediatrics Hospital das Clinicas FMRP-USP
São Paulo
Instituto da Crianca do Hospital das Clinicas da FMUSP Depto de Pediatria
Sao Paulo - SP
Instituto de Infectologia Emilio Ribas
Sao Paulo - SP
Universidade Federal de Sao Paulo
Vila Clementino
Hospital Infantil Nossa Senhora da Gloria Servico de Infectologia Pediatria
Vitoria - ES
About this study
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Tenofovir DF, Placebo
- Keywords
- Phase 3, Randomized, Double-Blind, Control, Treatment-Experienced, OBR, Optimized background regimen, Highly Active Antiretroviral Therapy, HAART, HIV, HIV-1, AIDS Virus, Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus, Virus, Human Immunodeficiency, Pediatrics
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir DFDrug
Tenofovir DF 300-mg tablet, administered orally, daily + OBR
PlaceboDrug
Tenofovir DF Placebo administered orally, daily + OBR
| Study group | Role | What they receive |
|---|---|---|
| OBR + Tenofovir DF | Experimental | Tenofovir DF administered orally, one tablet daily without regard to meals Receives: Drug: Tenofovir DF |
| OBR + Tenofovir DF Placebo | Placebo comparator | Placebo to match tenofovir DF administered orally, one tablet daily without regard to meals Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA
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.
Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed).
Measured: Baseline to 24 Weeks
Secondary outcomes (50)
Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA
DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.
Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed).
Measured: Baseline to 48 weeks
Change From Baseline to Week 24 in HIV-1 RNA
Measured: Baseline to 24 weeks
Change From Baseline to Week 48 in HIV-1 RNA
Measured: Baseline to 48 weeks
Change From Baseline to Week 96 in HIV-1 RNA
Measured: Baseline to 96 weeks
Change From Baseline to Week 144 in HIV-1 RNA
Measured: Baseline to 144 weeks
Change From Baseline to Week 192 in HIV-1 RNA
Measured: Baseline to 192 weeks
Change From Baseline to Week 240 in HIV-1 RNA
Measured: Baseline to 240 weeks
Change From Baseline to Week 288 in HIV-1 RNA
Measured: Baseline to 288 weeks
Change From Baseline to Week 336 in HIV-1 RNA
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measured: Baseline to 336 weeks
Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count
Measured: Baseline to 24 weeks
Change From Baseline to Week 48 in CD4 Count
Measured: Baseline to 48 weeks
Change From Baseline to Week 96 in CD4 Count
Measured: Baseline to 96 weeks
Change From Baseline to Week 144 in CD4 Count
Measured: Baseline to 144 weeks
Change From Baseline to Week 192 in CD4 Count
Measured: Baseline to 192 weeks
Change From Baseline to Week 240 in CD4 Count
Measured: Baseline to 240 weeks
Change From Baseline to Week 288 in CD4 Count
Measured: Baseline to 288 weeks
Change From Baseline to Week 336 in CD4 Count
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measured: Baseline to 336 weeks
Change From Baseline to Week 24 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measured: Baseline to 24 weeks
Change From Baseline to Week 48 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measured: Baseline to 48 weeks
Change From Baseline to Week 96 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measured: Baseline to 96 weeks
Change From Baseline to Week 144 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measured: Baseline to 144 weeks
Change From Baseline to Week 192 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measured: Baseline to 192 weeks
Change From Baseline to Week 240 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measured: Baseline to 240 weeks
Change From Baseline to Week 288 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measured: Baseline to 288 weeks
Change From Baseline to Week 336 in CD4 Percentage
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measured: Baseline to 336 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24
Measured: Baseline to 24 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48
Measured: Baseline to 48 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96
Measured: Baseline to 96 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144
Measured: Baseline to 144 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192
Measured: Baseline to 192 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240
Measured: Baseline to 240 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288
Measured: Baseline to 288 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measured: Baseline to 336 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24
Measured: Week 24
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Measured: Week 48
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Measured: Week 96
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Measured: Week 144
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192
Measured: Week 192
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240
Measured: Week 240
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288
Measured: Week 288
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measured: Week 336
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Measured: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Measured: Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Measured: Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
Measured: Week 144
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
Measured: Week 192
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240
Measured: Week 240
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288
Measured: Week 288
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measured: Week 336
Percentage of Participants With Virologic Failure Through Week 48
Virologic failure was defined as either nonresponse or viral rebound.
- Nonresponse (failure to achieve response). Response was defined as either
- A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or
- HIV-1 RNA < 400 copies/mL at 2 consecutive visits.
- Viral rebound was defined as either
- Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or
- Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.
The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2008
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Quirk, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352053
- Sponsor's protocol ID
- GS-US-104-0321
- Status last verified
- Jun 2015
- First submitted
- 13 Jul 2006
- Last updated
- 14 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00352053
- Acronym / sponsor ID
- GS-US-104-0321
- Conditions
- HIV Infections
- Keywords
- Phase 3, Randomized, Double-Blind, Control, Treatment-Experienced, OBR, Optimized background regimen, Highly Active Antiretroviral Therapy, HAART
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Posted 19 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBR + Tenofovir DF | Experimental | Drug: Tenofovir DFTenofovir DF administered orally, one tablet daily without regard to meals |
| OBR + Tenofovir DF Placebo | Placebo comparator | Drug: PlaceboPlacebo to match tenofovir DF administered orally, one tablet daily without regard to meals |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients requiring didanosine in background regimen
- Prior history of significant renal disease
- Prior history of significant bone disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir DFTenofovir DF 300-mg tablet, administered orally, daily + OBR | Drug | OBR + Tenofovir DF |
| PlaceboTenofovir DF Placebo administered orally, daily + OBR | Drug | OBR + Tenofovir DF Placebo |
Primary outcome
Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA
Time frame: Baseline to 24 Weeks
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. Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed).
50 secondary outcomes
Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA
Time frame: Baseline to 48 weeks
Change From Baseline to Week 24 in HIV-1 RNA
Time frame: Baseline to 24 weeks
Change From Baseline to Week 48 in HIV-1 RNA
Time frame: Baseline to 48 weeks
Change From Baseline to Week 96 in HIV-1 RNA
Time frame: Baseline to 96 weeks
Change From Baseline to Week 144 in HIV-1 RNA
Time frame: Baseline to 144 weeks
Change From Baseline to Week 192 in HIV-1 RNA
Time frame: Baseline to 192 weeks
Change From Baseline to Week 240 in HIV-1 RNA
Time frame: Baseline to 240 weeks
Change From Baseline to Week 288 in HIV-1 RNA
Time frame: Baseline to 288 weeks
Change From Baseline to Week 336 in HIV-1 RNA
Time frame: Baseline to 336 weeks
Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count
Time frame: Baseline to 24 weeks
Change From Baseline to Week 48 in CD4 Count
Time frame: Baseline to 48 weeks
Change From Baseline to Week 96 in CD4 Count
Time frame: Baseline to 96 weeks
Change From Baseline to Week 144 in CD4 Count
Time frame: Baseline to 144 weeks
Change From Baseline to Week 192 in CD4 Count
Time frame: Baseline to 192 weeks
Change From Baseline to Week 240 in CD4 Count
Time frame: Baseline to 240 weeks
Change From Baseline to Week 288 in CD4 Count
Time frame: Baseline to 288 weeks
Change From Baseline to Week 336 in CD4 Count
Time frame: Baseline to 336 weeks
Change From Baseline to Week 24 in CD4 Percentage
Time frame: Baseline to 24 weeks
Change From Baseline to Week 48 in CD4 Percentage
Time frame: Baseline to 48 weeks
Change From Baseline to Week 96 in CD4 Percentage
Time frame: Baseline to 96 weeks
Change From Baseline to Week 144 in CD4 Percentage
Time frame: Baseline to 144 weeks
Change From Baseline to Week 192 in CD4 Percentage
Time frame: Baseline to 192 weeks
Change From Baseline to Week 240 in CD4 Percentage
Time frame: Baseline to 240 weeks
Change From Baseline to Week 288 in CD4 Percentage
Time frame: Baseline to 288 weeks
Change From Baseline to Week 336 in CD4 Percentage
Time frame: Baseline to 336 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24
Time frame: Baseline to 24 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48
Time frame: Baseline to 48 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96
Time frame: Baseline to 96 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144
Time frame: Baseline to 144 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192
Time frame: Baseline to 192 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240
Time frame: Baseline to 240 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288
Time frame: Baseline to 288 weeks
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336
Time frame: Baseline to 336 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24
Time frame: Week 24
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Time frame: Week 48
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Time frame: Week 144
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192
Time frame: Week 192
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240
Time frame: Week 240
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288
Time frame: Week 288
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Quirk, MD study director
Gilead Sciences
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenofovir DF in people with HIV Infections, run by Gilead Sciences at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Brazil, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA (time frame: Baseline to 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.