HIV InfectionPhase 2NCT00196651
HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides in Patients Treated Early With HAART During Primary Infection
A Phase 2 study testing IL-2, LIPO-6T and ALVAC VIH 1433 in people with HIV Infection, run by French National Agency for Research on AIDS and Viral Hepatitis.
Trial summary
HIV-specific immune responses are preserved in patients treated early during primary infection.The trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuation 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?
- IL-2, LIPO-6T and ALVAC VIH 1433
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Feb 2004
- Phase
- Phase 2
- 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
- History of symptomatic HIV primary infection with p24 positive or incomplete Western Blot
- Treatment beginning before 4W after the first primary infection serology
- HAART with IP or NNRTI since one year, wtih no change since 3 months
- Viral load below 50 cp since 6 months
- PN over 1000/mm3;Hb over 10.5g/l;Platelets over 75000/mm3, creatinine below 1.5N; transaminases below 2.5N
Who cannot join
- Vaccination or chemotherapy or corticosteroid since 3 months
- Evolutive cancer
- pregnancy or breastfeeding
About this study
Official title: Randomized Study on HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides (LIPO-6T) in Patients Treated Early With HAART During Primary Infection. ANRS 095 PRIMOVAC
HIV-specific immune responses are preserved in patients treated early during primary infection.The trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuation
Read the detailed description
HIV-specific immune responses are preserved in patients treated early during primary infection. The trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuation.Patients treated with HAART are randomized to 3 arms:arm1 HAART alone; arm2 with 5 cycles of IL-2 at wk0 ,8 ,16 ,24 and 32;arm3 4 injections of Alvac-HIV 1433 and LIPO-6T at wk0,4,8 followed by 3 cycles of IL-2 at w 16, 24 and 32. HAART is stopped at wk 40 in patient with undetectable plasma viral load. Viral loads and HIV-specific responses are monitored during the therapeutic period and after HAART interruption until w52. HAARTis rei-initiated with viral failure.
- Conditions
- HIV Infection
- Being tested
- IL-2, LIPO-6T, ALVAC VIH 1433
- Keywords
- HIV infection, AIDS Vaccines, ALVAC vaccine, Interleukin-2, Antiretroviral Therapy, Highly Active
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2Drug
LIPO-6TBiological
ALVAC VIH 1433Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36
Secondary outcomes (4)
Safety of IL-2, ALVAC and LIPO-6T
Tolerability of HAART
Kinetic of viral load rebound with frequency and delay of cv over 10 000 cp and 50 000 cp
Evolution on immune response and predictive value of immunologic parameters on viral load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2000
- Study completionFeb 2004
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Aventis Pharmaceuticals
- Investigators
- Cecile Goujard, MD, Principal investigator, Hopital Kremlin Bicetre Bicetre FranceJean Pierre Aboulker, MD, Study director, Inserm SC10 France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196651
- Sponsor's protocol ID
- ANRS 095 PRIMOVAC
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Publications
Goujard C, Marcellin F, Hendel-Chavez H, Burgard M, Meiffredy V, Venet A, Rouzioux C, Taoufik Y, El Habib R, Beumont-Mauviel M, Aboulker JP, Levy Y, Delfraissy JF; PRIMOVAC-ANRS 095 Study Group. Interruption of antiretroviral therapy initiated during primary HIV-1 infection: impact of a therapeutic vaccination strategy combined with interleukin (IL)-2 compared with IL-2 alone in the ANRS 095 Randomized Study. AIDS Res Hum Retroviruses. 2007 Sep;23(9):1105-13. doi: 10.1089/aid.2007.0047.
PubMed 17919105
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides (LIPO-6T) in Patients Treated Early With HAART During Primary Infection. ANRS 095 PRIMOVAC
- ClinicalTrials.gov ID
- NCT00196651
- Acronym / sponsor ID
- ANRS 095 PRIMOVAC
- Conditions
- HIV Infection
- Keywords
- HIV infection, AIDS Vaccines, ALVAC vaccine, Interleukin-2, Antiretroviral Therapy, Highly Active
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Aug 2000
- Study completion
- Feb 2004
- First posted
- 20 Sep 2005 (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.
HIV-specific immune responses are preserved in patients treated early during primary infection.The trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuation
Detailed description
HIV-specific immune responses are preserved in patients treated early during primary infection. The trial evaluated whether the addition to HAART of IL-2 alone or combined with an immunization procedure might enhance HIV immune responses and improve viral control after HAART discontinuation.Patients treated with HAART are randomized to 3 arms:arm1 HAART alone; arm2 with 5 cycles of IL-2 at wk0 ,8 ,16 ,24 and 32;arm3 4 injections of Alvac-HIV 1433 and LIPO-6T at wk0,4,8 followed by 3 cycles of IL-2 at w 16, 24 and 32. HAART is stopped at wk 40 in patient with undetectable plasma viral load. Viral loads and HIV-specific responses are monitored during the therapeutic period and after HAART interruption until w52. HAARTis rei-initiated with viral failure.
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 (5 listed)
- History of symptomatic HIV primary infection with p24 positive or incomplete Western Blot
- Treatment beginning before 4W after the first primary infection serology
- HAART with IP or NNRTI since one year, wtih no change since 3 months
- Viral load below 50 cp since 6 months
- PN over 1000/mm3;Hb over 10.5g/l;Platelets over 75000/mm3, creatinine below 1.5N; transaminases below 2.5N
Key exclusion criteria (3 listed)
- Vaccination or chemotherapy or corticosteroid since 3 months
- Evolutive cancer
- pregnancy or breastfeeding
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 |
|---|---|---|
| IL-2 | Drug | – |
| LIPO-6T | Biological | – |
| ALVAC VIH 1433 | Biological | – |
Primary outcome
Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36
4 secondary outcomes
Safety of IL-2, ALVAC and LIPO-6T
Tolerability of HAART
Kinetic of viral load rebound with frequency and delay of cv over 10 000 cp and 50 000 cp
Evolution on immune response and predictive value of immunologic parameters on viral load
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 20 Sep 2005.
- Derived from this study: PubMed 17919105Goujard C, Marcellin F, Hendel-Chavez H, Burgard M, Meiffredy V, Venet A, Rouzioux C, Taoufik Y, El Habib R, Beumont-Mauviel M, Aboulker JP, Levy Y, Delfraissy JF; PRIMOVAC-ANRS 095 Study Group. Interruption of antiretroviral therapy initiated during primary HIV-1 infection: impact of a therapeutic vaccination strategy combined with interleukin (IL)-2 compared with IL-2 alone in the ANRS 095 Randomized Study. AIDS Res Hum Retroviruses. 2007 Sep;23(9):1105-13. doi: 10.1089/aid.2007.0047.
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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.
Cecile Goujard, MD principal investigator
Hopital Kremlin Bicetre Bicetre France
Jean Pierre Aboulker, MD study director
Inserm SC10 France
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IL-2, LIPO-6T and ALVAC VIH 1433 in people with HIV Infection, run by French National Agency for Research on AIDS and Viral Hepatitis.
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 5 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: stopped early, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evolution of CD4-CD8 non specific and HIV specific cells, vaccinal peptids and viral load with DNA proviral at W36. 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 NCT00196651, 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 20 Sep 2005; AzTrials last refreshed its copy on 8 Nov 2026.