Severely Immunocompromised HIV PatientsPhase 2/3IDEANCT01837277
Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
A Phase 2/3 study testing Dolutegravir 50 mg and Efavirenz-based regimens in people with Severely Immunocompromised HIV Patients, run by Fundação Bahiana de Infectologia at 3 sites in Brazil.
Trial summary
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severely Immunocompromised HIV Patients
- What is being tested?
- Dolutegravir 50 mg and Efavirenz-based regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 3 sitesBrazil
- Study dates
- 15 Dec 2017to 30 Sep 2021
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
- No previous use of any ARV drug (drug-naïve patients)
- Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
- Baseline CD4+ cells count equal or lower than 50 cells/mm3
- Age equal or higher than 18 years
- HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml
Who cannot join
- Undetectable plasma viral load at screening
- CD4 cells count>50 cells/mm3
- Asymptomatic individuals
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Fundação Bahiana de Infectologia/SEI
Salvador, Estado de Bahia, 40010-160
About this study
Official title: Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. There are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment, in comparison with the observed outcomes in developed countries. One of the consistently detected risks for early mortality across these reports is the baseline low CD4 count, although it does not seem to be the only reason for such outcome. In Brazil and other developing countries, there is still a large proportion of AIDS patients who are diagnosed with AIDS, or only seek health care for HIV infection late in the course of disease. Dolutegravir (DTG), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The investigators propose to compare the impact of DTG versus EFV in the early mortality rates for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.
- Conditions
- Severely Immunocompromised HIV Patients
- Being tested
- Dolutegravir 50 mg, Efavirenz-based regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 50 mgDrug
Also called Tivicay
Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID)
Efavirenz-based regimensDrug
Also called Efavirenz
Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir | Experimental | Intervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID Receives: Drug: Dolutegravir 50 mg |
| Efavirenz | Active comparator | Intervention: Patients who received ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year, befor the use of DTG as SOC for first-line therapy (historic controls) Receives: Drug: Efavirenz-based regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Mortality
Proportion of deaths in each group
Measured: 6 months
Secondary outcomes (2)
Viral Load
Measured: 24 months
CD4 Count
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study start15 Dec 2017
- Primary completion31 Jul 2021
- Study completion30 Sep 2021
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 Severely Immunocompromised HIV PatientsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Bahiana de Infectologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Brites, Fundação Bahiana de Infectologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837277
- Sponsor's protocol ID
- SevereHIV
- Acronym
- IDEA
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2013
- Last updated
- 14 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients
- ClinicalTrials.gov ID
- NCT01837277
- Acronym / sponsor ID
- IDEA / SevereHIV
- Conditions
- Severely Immunocompromised HIV Patients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Fundação Bahiana de InfectologiaUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Posted 14 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. There are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment, in comparison with the observed outcomes in developed countries. One of the consistently detected risks for early mortality across these reports is the baseline low CD4 count, although it does not seem to be the only reason for such outcome. In Brazil and other developing countries, there is still a large proportion of AIDS patients who are diagnosed with AIDS, or only seek health care for HIV infection late in the course of disease. Dolutegravir (DTG), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The investigators propose to compare the impact of DTG versus EFV in the early mortality rates for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir | Experimental | Drug: Dolutegravir 50 mgIntervention: Patients will receive ART regimen based on investigational drug Dolutegravir 50 mg QD + TDF 300 mg QD+ 3TC 150 mg BID |
| Efavirenz | Active comparator | Drug: Efavirenz-based regimensIntervention: Patients who received ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year, befor the use of DTG as SOC for first-line therapy (historic controls) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
- No previous use of any ARV drug (drug-naïve patients)
- Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
- Baseline CD4+ cells count equal or lower than 50 cells/mm3
- Age equal or higher than 18 years
Key exclusion criteria (3 listed)
- Undetectable plasma viral load at screening
- CD4 cells count>50 cells/mm3
- Asymptomatic individuals
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 |
|---|---|---|
| Dolutegravir 50 mgAlso: TivicayUse of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID) | Drug | Dolutegravir |
| Efavirenz-based regimensAlso: EfavirenzEfavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD) | Drug | Efavirenz |
Primary outcome
Early Mortality
Time frame: 6 months
Proportion of deaths in each group
2 secondary outcomes
Viral Load
Time frame: 24 months
CD4 Count
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dolutegravir 50 mg and Efavirenz-based regimens in people with Severely Immunocompromised HIV Patients, run by Fundação Bahiana de Infectologia at 3 sites 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 6 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Dec 2023). 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?
Early Mortality (time frame: 6 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 14 Dec 2023.