HIV InfectionsBRAVONCT00751530
BRAVO: Background Regimen of Raltegravir on Virologic Outcome
An observational study of HIV Infections, run by Community Research Initiative of New England at 15 sites in United States.
Trial summary
This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- raltegravir
- How many people
- 442 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Mar 2008to 15 Jun 2009
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of individuals who were previously enrolled in raltegravir expanded access program(EAP) and completed at least 8 weeks of treatment with raltegravir, whose chart from EAP program is available for review, and whose resistance testing prior to initiation of raltegravir is available.
Who may be able to join
- Patients previously enrolled in the MK 0518 EAP are eligible
- Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:
- Age >= 16 years
- Limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens, documented resistance to at least one drug in each of the 3 classes of oral ARTs (NRTI, NNRTI, PI) by genotype or phenotype testing, intolerance defined as having had a clinically significant adverse event which in the opinion of the clinician provides a contraindication to the use of any drug in that class iii. Patient did not achieve virologic suppression on ART regimen prior to receipt of raltegravir iv. Patient was clinically stable at time of initiation of raltegravir, eg. clinical status and all chronic medications (except ARTs) unchanged for >= 2 weeks prior to raltegravir receipt.
- Patient received raltegravir for at least 8 weeks
- Baseline and week 8 or later HIV viral load done and available for review
- Resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir
Who cannot join
- Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.
- Patient chart not available for review.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Community Research Initiative
Boston, Massachusetts, 02215
Infectious Diseases and HIV Medicine Immunodeficiency Clinic
Buffalo, New York, 14215
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
Dr. Nicholaos C. Bellos & Associates
Dallas, Texas, 75204
Connecticut Health Care Group
Glastonbury, Connecticut, 06033
Light Source Medical
Los Angeles, California, 900036
AIDS Healthcare Foundation
Los Angeles, California, 90028
Synergy Hematology and Oncology
Los Angeles, California, 90036
Bellman, MD
New York, New York, 10003
Orlando Immunology Center
Orlando, Florida, 32803
Mounzer, MD
Philadelphia, Pennsylvania, 19107
Quest Clinical Research
San Francisco, California, 94115
Community Research Initiative - West
Springfield, Massachusetts, 01107
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
Capital Medical Associates PC
Washington D.C., District of Columbia, 20036
About this study
Official title: Outcomes of Early Raltegravir Experience: Comparison of Virologic Response in Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen Versus a Protease Inhibitor in the Background Regimen
This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.
Read the detailed description
EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as GSS and PSS.
- Conditions
- HIV Infections
- Being tested
- raltegravir
- Keywords
- HIV, AIDS, raltegravir, BRAVO, protease inhibitor, treatment Experienced
- 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.
raltegravirDrug
New combination ART incorporating raltegravir with other ARVs.
| Study group | Role | What they receive |
|---|---|---|
| Protease Inhibitor Group | Subjects who required a protease inhibitor in their new ART regimen Receives: Drug: raltegravir | |
| Non-protease Inhibitor | Subjects who did not take a protease inhibitor in their regimen Receives: Drug: raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
Measured: 12 Weeks
Secondary outcomes (4)
Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12
The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
Measured: 12 weeks
CD4 Cell Changes Among Participants in PI vs Non-PI Group
CD4 cell counts were measured using standard of care testing via local laboratories.
Measured: baseline to 24 Weeks
Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)
The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.
Measured: Baseline
Percentage of Participants Using Etravirine in Background Regimen
These results report the percent of participants using Etravirine in the background regimen.
Measured: Background regimen (no specific time frame)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study start1 Mar 2008
- Primary completion15 Jun 2009
- Study completion15 Jun 2009
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Research Initiative of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Skiest, MD, Principal investigator, Community Research Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751530
- Sponsor's protocol ID
- 07-11
- Acronym
- BRAVO
- Status last verified
- Jul 2012
- First submitted
- 11 Sep 2008
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Raltegravir Experience: Comparison of Virologic Response in Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen Versus a Protease Inhibitor in the Background Regimen
- ClinicalTrials.gov ID
- NCT00751530
- Acronym / sponsor ID
- BRAVO / 07-11
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, raltegravir, BRAVO, protease inhibitor, treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Community Research Initiative of New EnglandUniversity, hospital or other
- Study start
- 1 Mar 2008 (actual)
- Primary completion
- 15 Jun 2009 (actual)
- Study completion
- 15 Jun 2009 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Posted 17 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.
Detailed description
EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as GSS and PSS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protease Inhibitor Group | – | Drug: raltegravirSubjects who required a protease inhibitor in their new ART regimen |
| Non-protease Inhibitor | – | Drug: raltegravirSubjects who did not take a protease inhibitor in their regimen |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of individuals who were previously enrolled in raltegravir expanded access program(EAP) and completed at least 8 weeks of treatment with raltegravir, whose chart from EAP program is available for review, and whose resistance testing prior to initiation of raltegravir is available.
Key inclusion criteria (7 listed)
- Patients previously enrolled in the MK 0518 EAP are eligible
- Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:
- Patient received raltegravir for at least 8 weeks
- Baseline and week 8 or later HIV viral load done and available for review
- Resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir
Key exclusion criteria (2 listed)
- Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.
- Patient chart not available for review.
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 |
|---|---|---|
| raltegravirNew combination ART incorporating raltegravir with other ARVs. | Drug | Non-protease Inhibitor, Protease Inhibitor Group |
Primary outcome
Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
Time frame: 12 Weeks
The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
4 secondary outcomes
Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12
Time frame: 12 weeks
CD4 Cell Changes Among Participants in PI vs Non-PI Group
Time frame: baseline to 24 Weeks
Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)
Time frame: Baseline
Percentage of Participants Using Etravirine in Background Regimen
Time frame: Background regimen (no specific time frame)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- 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.
Daniel Skiest, MD principal investigator
Community Research Initiative
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Community Research Initiative of New England at 15 sites 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 7 inclusion and 2 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2011). 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?
Percentage of Participants With Viral Load < 400 Copies /mL at Week 12. (time frame: 12 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 2 Jul 2017.