HIV InfectionPhase 4NCT01455688
Early Antiviral Therapy for Critically Ill HIV Infected Patients
A Phase 4 study testing early HAART and Late HAART in people with HIV Infection, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- early HAART and Late HAART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2012to 30 Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection
- CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age > 55 years, coinfection with HBV or HCV, neoplasia, viral load > 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness
Who cannot join
- Regular use of HAART
- Pregnant
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul
About this study
Official title: Early Antiretroviral Therapy for Critically Ill HIV Infected Patients
The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.
- Conditions
- HIV Infection
- Being tested
- early HAART, Late HAART
- Keywords
- critically ill patients, HIV infection, HAART, mortality
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early HAARTDrug
Initiation of HAART within 5 days of ICU admission
Late HAARTDrug
Initiation of HAART after ICU discharge
| Study group | Role | What they receive |
|---|---|---|
| Early antiviral therapy | Experimental | Not described Receives: Drug: early HAART |
| Conventional therapy | Active comparator | Not described Receives: Drug: Late HAART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
It is a estimative of length of hospital stay
Measured: 4 weeks
Secondary outcomes (1)
6-month mortality
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 posted20 Oct 2011 (estimated)
- Study start1 Jan 2012
- Primary completion31 Dec 2015
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455688
- Sponsor's protocol ID
- ARV-0112
- Status last verified
- Apr 2018
- First submitted
- 17 Oct 2011
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Boniatti MM, Pellegrini JAS, Marques LS, John JF, Marin LG, Maito LRDM, Lisboa TC, Damiani LP, Falci DR. Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial. PLoS One. 2020 Sep 21;15(9):e0239452. doi: 10.1371/journal.pone.0239452. eCollection 2020.
PubMed 32956419
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Antiretroviral Therapy for Critically Ill HIV Infected Patients
- ClinicalTrials.gov ID
- NCT01455688
- Acronym / sponsor ID
- ARV-0112
- Conditions
- HIV Infection
- Keywords
- critically ill patients, HIV infection, HAART, mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 20 Oct 2011 (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 aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early antiviral therapy | Experimental | Drug: early HAART |
| Conventional therapy | Active comparator | Drug: Late HAART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV infection
- CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age > 55 years, coinfection with HBV or HCV, neoplasia, viral load > 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness
Key exclusion criteria (2 listed)
- Regular use of HAART
- Pregnant
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 |
|---|---|---|
| early HAARTInitiation of HAART within 5 days of ICU admission | Drug | Early antiviral therapy |
| Late HAARTInitiation of HAART after ICU discharge | Drug | Conventional therapy |
Primary outcome
Hospital mortality
Time frame: 4 weeks
It is a estimative of length of hospital stay
1 secondary outcome
6-month mortality
Time frame: 6 months
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 12 Apr 2018.
- Derived from this study: PubMed 32956419Boniatti MM, Pellegrini JAS, Marques LS, John JF, Marin LG, Maito LRDM, Lisboa TC, Damiani LP, Falci DR. Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial. PLoS One. 2020 Sep 21;15(9):e0239452. doi: 10.1371/journal.pone.0239452. eCollection 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 early HAART and Late HAART in people with HIV Infection, run by Hospital Nossa Senhora da Conceicao 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 2 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 12 Apr 2018. 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?
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?
Hospital mortality (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01455688, which also lists 1 linked publication.
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 12 Apr 2018.