HIV InfectionsPhase 2HIVNCT00654147
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
A Phase 2 study testing Raltegravir & Lopinavir/ritonavir and Raltegravir and emtricitabine/tenofovir in people with HIV Infections, run by Margaret A. Fischl, M.D. at 1 site in United States.
Trial summary
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir & Lopinavir/ritonavir and Raltegravir and emtricitabine/tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2012
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV Infection
- Genotypic resistance without major resistance mutations within 30 days
- Antiretroviral drug-naïve
- Screening HIV-1 RNA ≥5000
- Women of reproductive potential
- Negative pregnancy test within 48 hours
Who cannot join
- Acute or recent HIV-1 infection
- Currently breast feeding
- Use of immunomodulators
- Evidence of major resistance mutations
- HBsAg positive
- Acute hepatitis of any etiology or clinically significant liver disease
- Current imprisonment or involuntary incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami AIDS Clinical Research Unit
Miami, Florida, 33136
About this study
Official title: A Pilot Study to Assess Virologic Suppression and Immune Recovery With Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with Raltegravir based regimens and their relationship with functional CD8 T cells and if Raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.
Read the detailed description
A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects.
HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC 200 mg/TDF 300 mg QD (Arm B).
Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry and entry. The average of these measurements will be used to establish their baseline values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.
- Conditions
- HIV Infections
- Being tested
- Raltegravir & Lopinavir/ritonavir, Raltegravir and emtricitabine/tenofovir
- Keywords
- HIV, antiretroviral therapy naive, Integrase inhibitor, HIV/AIDS, treatment naïve
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir & Lopinavir/ritonavirDrug
Also called Isentress, Kaletra
Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor
Raltegravir and emtricitabine/tenofovirDrug
Also called Isentress, Truvada
Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir & Lopinavir/ritonavir | Active comparator | Raltegravir 400 mg tablet and Lopinavir/ritonavir capsule by mouth, every 12 hours for 48 weeks Receives: Drug: Raltegravir & Lopinavir/ritonavir |
| Raltegravir & emtricitabine/tenofovir | Active comparator | Raltegravir 400 mg tablet bu mouth, every 12 hours for 48 weeks and tenofovir/embritcitabine 200 mg/100 mg table by mouth, once daily for 48 weeks Receives: Drug: Raltegravir and emtricitabine/tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Confirmed Virologic Failure
time to confirmed viologic failure at 24 weeks (up to 48 weeks)
Measured: weeks
Time to Virologic Failure
time to virologic failure at week 24 (up to 48 weeks)
Measured: week 24 (up to 48 weeks)
Secondary outcomes (4)
Study Medication Toxicity-related Discontinuation .
grade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity
Measured: 48 weeks
Weeks to HIV-1 RNA <200 Copies/ml
time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml
Measured: from date of treatment start to first week documented viral suppression
Change From Baseline CD4+ and CD8+ Cell Counts
mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms
Measured: Baseline, Weeks 16 and 24
Study Medication Tolerability
study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment
Measured: date started study treatment to first week documented change study treatment up to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2012
- Study completionJan 2012
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margaret A. Fischl, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Margaret A. Fischl, M.D., University of Miami
- Investigators
- Margaret A Fischl, M.D., Study chair, University of Miami AIDS Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654147
- Sponsor's protocol ID
- A009
- Acronym
- HIV
- Status last verified
- Jul 2015
- First submitted
- 2 Apr 2008
- Last updated
- 3 Aug 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 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Virologic Suppression and Immune Recovery With Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects
- ClinicalTrials.gov ID
- NCT00654147
- Acronym / sponsor ID
- HIV / A009
- Conditions
- HIV Infections
- Keywords
- HIV, antiretroviral therapy naive, Integrase inhibitor, HIV/AIDS, treatment naïve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Margaret A. Fischl, M.D.University, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Posted 13 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with Raltegravir based regimens and their relationship with functional CD8 T cells and if Raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.
Detailed description
A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects.
HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC 200 mg/TDF 300 mg QD (Arm B).
Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry and entry. The average of these measurements will be used to establish their baseline values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir & Lopinavir/ritonavir | Active comparator | Drug: Raltegravir & Lopinavir/ritonavirRaltegravir 400 mg tablet and Lopinavir/ritonavir capsule by mouth, every 12 hours for 48 weeks |
| Raltegravir & emtricitabine/tenofovir | Active comparator | Drug: Raltegravir and emtricitabine/tenofovirRaltegravir 400 mg tablet bu mouth, every 12 hours for 48 weeks and tenofovir/embritcitabine 200 mg/100 mg table by mouth, once daily for 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV Infection
- Genotypic resistance without major resistance mutations within 30 days
- Antiretroviral drug-naïve
- Screening HIV-1 RNA ≥5000
- Women of reproductive potential
Key exclusion criteria (7 listed)
- Acute or recent HIV-1 infection
- Currently breast feeding
- Use of immunomodulators
- Evidence of major resistance mutations
- HBsAg positive
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 |
|---|---|---|
| Raltegravir & Lopinavir/ritonavirAlso: Isentress, KaletraTwo drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor | Drug | Raltegravir & Lopinavir/ritonavir |
| Raltegravir and emtricitabine/tenofovirAlso: Isentress, TruvadaThree drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors | Drug | Raltegravir & emtricitabine/tenofovir |
Primary outcome
Time to Confirmed Virologic Failure
Time frame: weeks
time to confirmed viologic failure at 24 weeks (up to 48 weeks)
Time to Virologic Failure
Time frame: week 24 (up to 48 weeks)
time to virologic failure at week 24 (up to 48 weeks)
4 secondary outcomes
Study Medication Toxicity-related Discontinuation .
Time frame: 48 weeks
Weeks to HIV-1 RNA <200 Copies/ml
Time frame: from date of treatment start to first week documented viral suppression
Change From Baseline CD4+ and CD8+ Cell Counts
Time frame: Baseline, Weeks 16 and 24
Study Medication Tolerability
Time frame: date started study treatment to first week documented change study treatment up to week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 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.
Margaret A Fischl, M.D. study chair
University of Miami AIDS Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raltegravir & Lopinavir/ritonavir and Raltegravir and emtricitabine/tenofovir in people with HIV Infections, run by Margaret A. Fischl, M.D. at 1 site in United States.
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 6 inclusion and 7 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 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Jul 2015). 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 to Confirmed Virologic Failure (time frame: weeks). The study lists 2 primary outcomes in all. 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 3 Aug 2015.