HIV InfectionsPhase 4ADVANZ-3NCT00532168
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
A Phase 4 study testing tenofovir + emtricitabine + efavirenz, tenofovir + emtricitabine + lopinavir-ritonavir and tenofovir + emtricitabine + atazanavir-ritonavir in people with HIV Infections, 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 three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- tenofovir + emtricitabine + efavirenz, tenofovir + emtricitabine + lopinavir-ritonavir and tenofovir + emtricitabine + atazanavir-ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2007to Dec 2012
- 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
- Chronic HIV-1 infection
- Age 18 or more
- Antiretroviral-naive
- Baseline CD4+ count <100 cels/mcL.
- No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
- Written informed consent
Who cannot join
- Hypersensibility to study drugs.
- Pregnancy or breastfeeding
- Active OI requiring admission
- Active lymphoma or malignancy (Kaposi sarcoma included)
- Cl creatinine below 30 ml/min.
- Liver failure
- Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-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.
- Conditions
- HIV Infections
- Being tested
- tenofovir + emtricitabine + efavirenz, tenofovir + emtricitabine + lopinavir-ritonavir, tenofovir + emtricitabine + atazanavir-ritonavir
- Keywords
- advanced HIV-infected patients, late presenters, antiretroviral therapy, immune reconstitution, 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.
tenofovir + emtricitabine + efavirenzDrug
tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
tenofovir + emtricitabine + lopinavir-ritonavirDrug
tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
tenofovir + emtricitabine + atazanavir-ritonavirDrug
tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | tenofovir plus emtricitabine plus efavirenz Receives: Drug: tenofovir + emtricitabine + efavirenz |
| 2 | Experimental | tenofovir plus emtricitabine plus lopinavir-ritonavir Receives: Drug: tenofovir + emtricitabine + lopinavir-ritonavir |
| 3 | Experimental | tenofovir plus emtricitabine plus atazanavir-ritonavir Receives: Drug: tenofovir + emtricitabine + atazanavir-ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned
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 posted20 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2012
- Study completionDec 2012
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 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
- Investigators
- Jose M Miró, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532168
- Sponsor's protocol ID
- ADVANZ-3
- Other IDs
- EudraCT: 2006-006268-42, FIS grant: EC07/90642
- Acronym
- ADVANZ-3
- Status last verified
- Feb 2013
- First submitted
- 18 Sep 2007
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Miro JM, Manzardo C, Ferrer E, Lonca M, Guardo AC, Podzamczer D, Domingo P, Curran A, Clotet B, Cruceta A, Lozano F, Perez I, Plana M, Gatell JM; Advanz-3 Study Group. Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial). J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):206-15. doi: 10.1097/QAI.0000000000000567.
PubMed 25831464
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.
- ClinicalTrials.gov ID
- NCT00532168
- Acronym / sponsor ID
- ADVANZ-3 / ADVANZ-3
- Conditions
- HIV Infections
- Keywords
- advanced HIV-infected patients, late presenters, antiretroviral therapy, immune reconstitution, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Sep 2007 (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 three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tenofovir + emtricitabine + efavirenztenofovir plus emtricitabine plus efavirenz |
| 2 | Experimental | Drug: tenofovir + emtricitabine + lopinavir-ritonavirtenofovir plus emtricitabine plus lopinavir-ritonavir |
| 3 | Experimental | Drug: tenofovir + emtricitabine + atazanavir-ritonavirtenofovir plus emtricitabine plus atazanavir-ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic HIV-1 infection
- Age 18 or more
- Antiretroviral-naive
- Baseline CD4+ count <100 cels/mcL.
- No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
Key exclusion criteria (7 listed)
- Hypersensibility to study drugs.
- Pregnancy or breastfeeding
- Active OI requiring admission
- Active lymphoma or malignancy (Kaposi sarcoma included)
- Cl creatinine below 30 ml/min.
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 |
|---|---|---|
| tenofovir + emtricitabine + efavirenztenofovir + emtricitabine + efavirenz, approved dose, oral route, QD | Drug | 1 |
| tenofovir + emtricitabine + lopinavir-ritonavirtenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose | Drug | 2 |
| tenofovir + emtricitabine + atazanavir-ritonavirtenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD | Drug | 3 |
Primary outcome
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned
Time frame: 48 weeks
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 22 Feb 2013.
- Derived from this study: PubMed 25831464Miro JM, Manzardo C, Ferrer E, Lonca M, Guardo AC, Podzamczer D, Domingo P, Curran A, Clotet B, Cruceta A, Lozano F, Perez I, Plana M, Gatell JM; Advanz-3 Study Group. Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial). J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):206-15. doi: 10.1097/QAI.0000000000000567.
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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.
Jose M Miró, MD study chair
Hospital Clinic of Barcelona
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 tenofovir + emtricitabine + efavirenz, tenofovir + emtricitabine + lopinavir-ritonavir and tenofovir + emtricitabine + atazanavir-ritonavir in people with HIV Infections, 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 7 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 22 Feb 2013. 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?
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?
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned (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 NCT00532168, 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 22 Feb 2013.