HIV InfectionPhase 4NCT00386659
Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.
A Phase 4 study testing tenofovir + abacavir + lopinavir/ritonavir and tenofovir + abacavir + efavirenz in people with HIV Infection, run by Hospital Clinic of Barcelona at 4 sites in Spain.
Trial summary
Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together… 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?
- tenofovir + abacavir + lopinavir/ritonavir and tenofovir + abacavir + efavirenz
- How many people
- 60 participants
- Where
- 4 sitesSpain
- Study dates
- Start not givento not given
- 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
- Antiretroviral-naive
- CD4 cell count below 100 cells/mm3
Who cannot join
- Pregnancy
- Current opportunistic infection requiring parenteral therapy
- Current malignancies requiring parenteral chemotherapy
- Any contraindication to the study drugs
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital de Sant Pau
Barcelona, Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clinic
Barcelona, Barcelona, 08036
CSU Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3
Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.
- Conditions
- HIV Infection
- Being tested
- tenofovir + abacavir + lopinavir/ritonavir, tenofovir + abacavir + efavirenz
- 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 + abacavir + lopinavir/ritonavirDrug
tenofovir + abacavir + efavirenzDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
Secondary outcomes (3)
Degree and kinetics of recovery of the immune system.
New CDC C events
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Josep M Gatell, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386659
- Sponsor's protocol ID
- ADVAN-Z-2
- Status last verified
- Oct 2006
- First submitted
- 10 Oct 2006
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3
- ClinicalTrials.gov ID
- NCT00386659
- Acronym / sponsor ID
- ADVAN-Z-2
- Conditions
- HIV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- First posted
- 11 Oct 2006 (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.
Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infection
- Antiretroviral-naive
- CD4 cell count below 100 cells/mm3
Key exclusion criteria (4 listed)
- Pregnancy
- Current opportunistic infection requiring parenteral therapy
- Current malignancies requiring parenteral chemotherapy
- Any contraindication to the study drugs
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 + abacavir + lopinavir/ritonavir | Drug | – |
| tenofovir + abacavir + efavirenz | Drug | – |
Primary outcome
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
3 secondary outcomes
Degree and kinetics of recovery of the immune system.
New CDC C events
Mortality
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
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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.
Josep M Gatell, MD study chair
Hospital Clinic of Barcelona
4 sites 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 + abacavir + lopinavir/ritonavir and tenofovir + abacavir + efavirenz in people with HIV Infection, run by Hospital Clinic of Barcelona at 4 sites 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early. 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?
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 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 11 Oct 2006.