HIV InfectionsPhase 4NCT01049685
Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy
A Phase 4 study testing First-line Antiretroviral Therapy in people with HIV Infections, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary endpoint: virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- First-line Antiretroviral Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Mar 2010
- Phase
- Phase 4
- 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
Who may be able to join
- HIV-1 infected naive-treatment patients
Who cannot join
- use of Anti-Retroviral Agents in the past
Trial locations and contacts
1 site in 1 country.
Brazil1 site
SAE e Hospital Dia Domingos Alves Meira
Botucatu, São Paulo, 18603-790
About this study
Official title: Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study
Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary endpoint: virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study.
Read the detailed description
Background: Either LPV/r or EFZ plus a two nucleoside reverse-transcriptase inhibitors (NRTIs) are recommended by the current guidelines all around the world as the main background drugs for initial therapy of human immunodeficiency virus type 1 (HIV-1) infection. This indication is based in results of clinical trials, but patients who participate in these studies usually are greatly motivated to continue their prescribed regimen, and can be different from the "real life". Therefore, clinical practice often cannot reproduce published results.
Methods: A retrospective longitudinal cohort study was performed with 36 naïve-treatment patients, who started therapy with LPV/r or EFZ, with follow-up of 36 months. The primary endpoint was virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study. Effectiveness was examined comparing time to virological failure and CD4 recovery.
- Conditions
- HIV Infections
- Being tested
- First-line Antiretroviral Therapy
- Keywords
- HIV, Antiretroviral Therapy, Highly Active, Efavirenz, Lopinavir, Comparative Effectiveness Research, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-line Antiretroviral TherapyDrug
Also called Sustiva, Kaletra
- Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background
- Efavirenz: 01 capsules day, plus NRTI background
| Study group | Role | What they receive |
|---|---|---|
| Efavirenz Group | Active comparator | Naïve-treatment HIV patients, who started therapy with Efavirenz Receives: Drug: First-line Antiretroviral Therapy |
| Lopinavir/r Group | Active comparator | Naïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir Receives: Drug: First-line Antiretroviral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance HIV RNA <50 copies/mL at the end oh 36 months
Measured: 36 months
Secondary outcomes (1)
Achieve HIV RNA <50 copies/mL at the first 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startAug 2006
- Primary completionDec 2009
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Alexandre N Barbosa, MD, MSc, Principal investigator, Botucatu School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049685
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-38
- Status last verified
- Jan 2010
- First submitted
- 11 Jan 2010
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lopinavir/Ritonavir or Efavirenz as First-line Antiretroviral Therapy in Brazil: a "Real Life" Study
- ClinicalTrials.gov ID
- NCT01049685
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-38
- Conditions
- HIV Infections
- Keywords
- HIV, Antiretroviral Therapy, Highly Active, Efavirenz, Lopinavir, Comparative Effectiveness Research, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (estimated)
- First posted
- 14 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.
Retrospective longitudinal cohort study with 36 HIV naïve-treatment patients, who started therapy with lopinavir/ritonavir or efavirenz (LPV/r or EFZ), follow-up of 36 months. Primary endpoint: virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study.
Detailed description
Background: Either LPV/r or EFZ plus a two nucleoside reverse-transcriptase inhibitors (NRTIs) are recommended by the current guidelines all around the world as the main background drugs for initial therapy of human immunodeficiency virus type 1 (HIV-1) infection. This indication is based in results of clinical trials, but patients who participate in these studies usually are greatly motivated to continue their prescribed regimen, and can be different from the "real life". Therefore, clinical practice often cannot reproduce published results.
Methods: A retrospective longitudinal cohort study was performed with 36 naïve-treatment patients, who started therapy with LPV/r or EFZ, with follow-up of 36 months. The primary endpoint was virological success (HIV RNA <50 copies/mL) in the first six months and at the end of the study. Effectiveness was examined comparing time to virological failure and CD4 recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efavirenz Group | Active comparator | Drug: First-line Antiretroviral TherapyNaïve-treatment HIV patients, who started therapy with Efavirenz |
| Lopinavir/r Group | Active comparator | Drug: First-line Antiretroviral TherapyNaïve-treatment HIV patients, who started therapy with Lopinavir/ritonavir |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-1 infected naive-treatment patients
Key exclusion criteria (1 listed)
- use of Anti-Retroviral Agents in the past
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 |
|---|---|---|
| First-line Antiretroviral TherapyAlso: Sustiva, Kaletra* Lopinavir/ritonavir: 02 capsules 12/12h, plus NRTI background * Efavirenz: 01 capsules day, plus NRTI background | Drug | Efavirenz Group, Lopinavir/r Group |
Primary outcome
Maintenance HIV RNA <50 copies/mL at the end oh 36 months
Time frame: 36 months
1 secondary outcome
Achieve HIV RNA <50 copies/mL at the first 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
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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.
Alexandre N Barbosa, MD, MSc principal investigator
Botucatu School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing First-line Antiretroviral Therapy in people with HIV Infections, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 2010. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Maintenance HIV RNA <50 copies/mL at the end oh 36 months (time frame: 36 months). 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 Feb 2010.