Treatment Failure, HIV or AIDSNCT01044810
Effectiveness of Efavirenz-based Regimen in HIV-1-infected Patients With Nevirapine Hypersensitivity
An observational study of Treatment Failure, HIV or AIDS and CD4 Cell Counts, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
Trial summary
The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment Failure, HIV or AIDS, CD4 Cell Counts
- What is being tested?
- Efavirenz-based regimens
- Type of treatment
- Pill or oral medicine
- How many people
- 559 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients who started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
Who may be able to join
- age 18-70 years old
- documented HIV infection
- started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
Who cannot join
- previously received non-HAART regimens such as dual NRTIs regimen, AZT monotherapy with single-dose NVP in pregnancy patients
- previously received protease inhibitor-based regimen
- diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, ESRD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine
The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an initial regimen (as controlled group).
- Conditions
- Treatment Failure, HIV or AIDS, CD4 Cell Counts
- Being tested
- Efavirenz-based regimens
- Keywords
- HIV, efavirenz, nevirapine, allergy, rash, Cohort Studies, Historical, Retrospective Study, exanthem, Antiretroviral Agents, Highly Active Antiretroviral Therapy, HAART, treatment failure
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hypersensitivity, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efavirenz-based regimensDrug
Also called Stocrin, Sustiva
Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous interruption (Exposure gr) | stopped all drugs in NNRTI-based regimens simultaneously after allergic reactions to NVP-based regimens, and later started EFV-based regimens Receives: Drug: Efavirenz-based regimens | |
| Naive (Control group) | HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens. Receives: Drug: Efavirenz-based regimens | |
| staggered interruption (exposure group) | after having allergic reactions to NVP-based regimens, stopped NNRTIs first, continued the other NRTIs for a period of time, i.e. "staggered interruption", and later started EFV-based regimens Receives: Drug: Efavirenz-based regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Virological failure
Virological failure was defined as either (1) two consecutive results of plasma HIV-1 RNA >400 copies/ml or (2) plasma HIV-1 RNA >1,000 copies/ml with genotypic resistance assay revealed NRTI or NNRTI resistance-associated mutations
Measured: until end of study cohort
Secondary outcomes (4)
Virological suppression
Virological suppression was defined as having plasma HIV-1 RNA <50 copies/ml
Measured: 24 months
Median increase from baseline of CD4 cell count
Measured: 24 months
Adverse events
Adverse events were defined as either (1) having more than grade 3 according to DAID AE Grading Table, or (2) having clinical events that leaded to changed antiretroviral medications
Measured: until end of cohort
Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events
Measured: until end of cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Failure, HIV or AIDSStudies 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
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bamrasnaradura Infectious Diseases Institute
- Sponsor type
- Other government
- Collaborators
- Thai Red Cross AIDS Research Centre, Clinical Research Collaborative Network
- Investigators
- Krittaecho Siripassorn, MD, Principal investigator, Bamrasnaradura Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044810
- Sponsor's protocol ID
- BIDI-EFV
- Status last verified
- Mar 2011
- First submitted
- 7 Jan 2010
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine
- ClinicalTrials.gov ID
- NCT01044810
- Acronym / sponsor ID
- BIDI-EFV
- Conditions
- Treatment Failure, HIV or AIDS, CD4 Cell Counts
- Keywords
- HIV, efavirenz, nevirapine, allergy, rash, Cohort Studies, Historical, Retrospective Study, exanthem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Bamrasnaradura Infectious Diseases InstituteOther government
- Collaborators
- Thai Red Cross AIDS Research Centre, Clinical Research Collaborative Network
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an initial regimen (as controlled group).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simultaneous interruption (Exposure gr) | – | Drug: Efavirenz-based regimensstopped all drugs in NNRTI-based regimens simultaneously after allergic reactions to NVP-based regimens, and later started EFV-based regimens |
| Naive (Control group) | – | Drug: Efavirenz-based regimensHIV-1-infected patients who started EFV-based regimens as their initial ARV regimens. |
| staggered interruption (exposure group) | – | Drug: Efavirenz-based regimensafter having allergic reactions to NVP-based regimens, stopped NNRTIs first, continued the other NRTIs for a period of time, i.e. "staggered interruption", and later started EFV-based regimens |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients who started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
Key inclusion criteria (3 listed)
- age 18-70 years old
- documented HIV infection
- started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
Key exclusion criteria (3 listed)
- previously received non-HAART regimens such as dual NRTIs regimen, AZT monotherapy with single-dose NVP in pregnancy patients
- previously received protease inhibitor-based regimen
- diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, ESRD
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 |
|---|---|---|
| Efavirenz-based regimensAlso: Stocrin, SustivaEfavienz: 600 mg, oral, every 24 hours, continued medication until the end of study. | Drug | Naive (Control group), Simultaneous interruption (Exposure gr), staggered interruption (exposure group) |
Primary outcome
Time to Virological failure
Time frame: until end of study cohort
Virological failure was defined as either (1) two consecutive results of plasma HIV-1 RNA >400 copies/ml or (2) plasma HIV-1 RNA >1,000 copies/ml with genotypic resistance assay revealed NRTI or NNRTI resistance-associated mutations
4 secondary outcomes
Virological suppression
Time frame: 24 months
Median increase from baseline of CD4 cell count
Time frame: 24 months
Adverse events
Time frame: until end of cohort
Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events
Time frame: until end of cohort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
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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.
Krittaecho Siripassorn, MD principal investigator
Bamrasnaradura Infectious Diseases Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Failure, HIV or AIDS and CD4 Cell Counts, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
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 3 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 15 Mar 2011. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Virological failure (time frame: until end of study cohort). 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 15 Mar 2011.