Efficacy of Using Interleukin-2 in Antiretroviral Naïve HIV Patients (ANRS119)
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ClinicalTrials.gov Identifier: NCT00120185 |
Recruitment Status
:
Completed
First Posted
: July 15, 2005
Last Update Posted
: December 22, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Interleukin-2 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of the Immunological Efficacy of Using Subcutaneous Interleukin-2 (IL-2) in Antiretroviral Naïve HIV-1-Infected Subjects With a CD4 Cell Count Above 300/mm3. ANRS 119 Trial INTERSTART |
Study Start Date : | December 2003 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | November 2006 |

- Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96
- Group B or C events (1993 CDC classification of HIV infection)
- Initiation of antiretroviral therapy
- Evolution of the CD4 count during the study
- Time to the first visit with a CD4 count below 300/mm3
- Tolerance of IL-2
- Evolution of the plasma HIV RNA load
- Evolution of the HIV DNA level in PBMCs
- Quality of life at W96
- Assessment of lipodystrophy at W96
- Immunological substudies (CD4 homeostasis, anti HIV cellular immune responses) at W96

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients with proven HIV-1-infection
- No prior exposition to antiretrovirals
- CD4 cell count between 300 and 500/mm3
- Signed written inform consent
Exclusion Criteria:
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120185
France | |
Service des Maladies Infectieuses | |
Paris, France, 75010 |
Principal Investigator: | Jean-Michel Molina, MD | Hopital Saint Louis Paris service des Maladies infectieuses et Tropicales | |
Study Chair: | Jean-Pierre Aboulker, MD | Inserm SC10 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00120185 History of Changes |
Other Study ID Numbers: |
2004-003897-27 ANRS119 Interstart |
First Posted: | July 15, 2005 Key Record Dates |
Last Update Posted: | December 22, 2011 |
Last Verified: | December 2011 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV Infections Interleukin-2 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Interleukin-2 Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |