Acquired Immune Deficiency Syndrome VirusPhase 4NCT02337322
Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir
A Phase 4 study testing Dolutegravir and Darunavir/r in people with Acquired Immune Deficiency Syndrome Virus, run by Juan A. Arnaiz at 1 site in Spain.
Trial summary
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immune Deficiency Syndrome Virus
- What is being tested?
- Dolutegravir and Darunavir/r
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 31 Mar 2015to Dec 2019
- 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 patients > 18 years old who provide signed and dated informed consent.
- Male and female.
- Chronic HIV infection.
- Antiretroviral naïve.
- Confirmed CD4+ T cell count below 100 cells/mm3
- HLA B5701 negative patients.
Who cannot join
- Active opportunistic infections requiring parenteral treatment
- Patients with cryptococcal meningitis treated with voriconazole
- AIDS-defining cancers needing chemotherapy.
- Female patients pregnant or breastfeeding.
- Patients with documented history of allergy to sulfonamides.
- Any contraindications to study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV-1-Infected Patients (<100 CD4+ T Cells/μL) Taking Antiretroviral Regimens Based on Dolutegravir or Ritonavir-boosted Darunavir (the Advanz-4 Trial).
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
- Being tested
- Dolutegravir, Darunavir/r
- Keywords
- Acquired Immune Deficiency Syndrome Virus, HIV, HIV-1, Antiretroviral treatment, HIV Advanced Disease, AIDS, Dolutegravir, Darunavir
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Darunavir/rDrug
Also called Ritonavir-boosted Darunavir
| Study group | Role | What they receive |
|---|---|---|
| ABC+3TC+DTG | Active comparator | Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen Receives: Drug: Dolutegravir |
| ABC+3TC+DRV/r | Active comparator | Abacavir+lamivudine+ritonavir-boosted darunavir, QD Receives: Drug: Darunavir/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median CD4 T cell count increase
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start31 Mar 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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 Acquired Immune Deficiency Syndrome VirusStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337322
- Sponsor's protocol ID
- Advanz-4
- Status last verified
- Aug 2018
- First submitted
- 9 Jan 2015
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miro JM, Torres F, Manzardo C, Bonfill E, Curran A, Domingo P, Podzamczer D, Paredes R, Force L, Falco V, Gutierrez M, Saumoy M, Castelli A, Inciarte A, Rovira C, Cruceta A, Hurtado C, Climent N, Lozano F, Plana M; Advanz-4 investigators. Immune reconstitution in very advanced HIV patients treated with dolutegravir vs. darunavir-based triple antiretroviral therapy: the Advanz-4 randomized clinical trial. Clin Microbiol Infect. 2026 Jan;32(1):169-176. doi: 10.1016/j.cmi.2025.09.026. Epub 2025 Oct 11.
PubMed 41083105
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV-1-Infected Patients (<100 CD4+ T Cells/μL) Taking Antiretroviral Regimens Based on Dolutegravir or Ritonavir-boosted Darunavir (the Advanz-4 Trial).
- ClinicalTrials.gov ID
- NCT02337322
- Acronym / sponsor ID
- Advanz-4
- Keywords
- Acquired Immune Deficiency Syndrome Virus, HIV, HIV-1, Antiretroviral treatment, HIV Advanced Disease, AIDS, Dolutegravir, Darunavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Jan 2015 (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.
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABC+3TC+DTG | Active comparator | Drug: DolutegravirAbacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen |
| ABC+3TC+DRV/r | Active comparator | Drug: Darunavir/rAbacavir+lamivudine+ritonavir-boosted darunavir, QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV patients > 18 years old who provide signed and dated informed consent.
- Male and female.
- Chronic HIV infection.
- Antiretroviral naïve.
- Confirmed CD4+ T cell count below 100 cells/mm3
Key exclusion criteria (6 listed)
- Active opportunistic infections requiring parenteral treatment
- Patients with cryptococcal meningitis treated with voriconazole
- AIDS-defining cancers needing chemotherapy.
- Female patients pregnant or breastfeeding.
- Patients with documented history of allergy to sulfonamides.
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 | Drug | ABC+3TC+DTG |
| Darunavir/rAlso: Ritonavir-boosted Darunavir | Drug | ABC+3TC+DRV/r |
Primary outcome
Median CD4 T cell count increase
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Derived from this study: PubMed 41083105Miro JM, Torres F, Manzardo C, Bonfill E, Curran A, Domingo P, Podzamczer D, Paredes R, Force L, Falco V, Gutierrez M, Saumoy M, Castelli A, Inciarte A, Rovira C, Cruceta A, Hurtado C, Climent N, Lozano F, Plana M; Advanz-4 investigators. Immune reconstitution in very advanced HIV patients treated with dolutegravir vs. darunavir-based triple antiretroviral therapy: the Advanz-4 randomized clinical trial. Clin Microbiol Infect. 2026 Jan;32(1):169-176. doi: 10.1016/j.cmi.2025.09.026. Epub 2025 Oct 11.
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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 Dolutegravir and Darunavir/r in people with Acquired Immune Deficiency Syndrome Virus, run by Juan A. Arnaiz at 1 site in Spain.
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 6 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 3 Aug 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 Spain. 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?
Median CD4 T cell count increase (time frame: 48 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 NCT02337322, 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 3 Aug 2018.