Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression
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ClinicalTrials.gov Identifier: NCT00125814 |
Recruitment Status :
Terminated
First Posted : August 2, 2005
Last Update Posted : August 16, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Interferon alfa-2b Procedure: Structured treatment interruptions | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multi-Center Trial to Evaluate the Efficacy and Safety of Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression (ANRS 105 INTERVAC) |
Study Start Date : | December 2001 |
Study Completion Date : | January 2005 |
- Proportion of patients who did not reach the criteria to resume antiretroviral treatment at week 72 [W 72] (viral load over 30000 cp/ml at two consecutive monthly samples and/or CD4 count below 350/mm3 at two consecutive monthly samples)
- Viral rebound one and 3 months after stopping all antiviral treatments
- Specific anti-HIV CD4 and CD8 response
- Proviral HIV DNA at baseline and during follow-up
- Description of genetic HIV viral mutations during procedure
- Safety

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- Males and non pregnant females
- Confirmed laboratory diagnosis of HIV infection
- Have been on the same continuous HAART regimen for at least 6 months prior to inclusion
- Viral load below 50 cp/ml for at least 6 months
- CD4 over 350 cells/mm3
- Previous viral load over 10000 cp/ml in their history
- No CD4 cell count under 100/mm3 in their history
- For women of reproductive ages: negative serum pregnancy test
- Signed written consent to participate.
Exclusion Criteria:
- Already had interferon or interleukin-2 (IL-2)
- Positive hepatitis C virus (HCV) PCR
- Under treatment with abacavir during screening
- Serious psychiatric history, suicide attempt, or severe depression
- History of thyroid abnormality
- Opportunistic infection ongoing
- Lymphoma or Kaposi's sarcoma (KS) under chemotherapy

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): NCT00125814
France | |
Service de Medecine Interne | |
Clamart, France, 92140 |
Principal Investigator: | François Boue, MD | Hopital Antoine Beclere service de Medecine Interne Clamart France | |
Study Chair: | Dominique Costagliola | INSERM U 720 |
ClinicalTrials.gov Identifier: | NCT00125814 |
Other Study ID Numbers: |
ANRS 105 INTERVAC |
First Posted: | August 2, 2005 Key Record Dates |
Last Update Posted: | August 16, 2005 |
Last Verified: | August 2005 |
Interferon Alfa-2b HIV infections |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Interferons Interferon-alpha Interferon alpha-2 Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |