Long-Term Supervised Treatment Interruption in HIV-Infected Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial is aimed at studying the safety of long term supervised treatment interruption in HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Procedure: Treatment interruption |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Long-Term Supervised Treatment Interruption in HIV-Infected Patients Who Started Antiretroviral Treatment With CD4 Over 350/mm3 and Plasma HIV RNA Below 50 000/mL ANRS 116 Trial SALTO |
- Proportion of patients who did not resume antiretroviral treatment at 12 months
- Time to resume antiretroviral treatment with CD4 cell count equal or below 300/mm3
- Proportion of patients who did not resume antiretroviral treatment at M 24 and M 36
- Predictive factors associated with the time of restart of antiretroviral therapy: Proviral HIV DNA at baseline and during follow-up
- Plasma HIV RNA at baseline and during follow-up
- CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months
- Change in lipodystrophy clinical score and quality of life during the follow-up
- Criteria to resume antiretroviral treatment: CD4T cell count below or equal to 300/mm3
- The occurrence of an AIDS defining event
| Estimated Enrollment: | 130 |
| Study Start Date: | February 2003 |
| Study Completion Date: | May 2007 |
The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection are associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart.
In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving HAART now in whom treatment would not have been started based on current guidelines), we evaluated the safety of long term supervised treatment interruption. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and non pregnant females
- 18 years of age and older
- Who have confirmed laboratory diagnosis of HIV infection
- Started on first line antiretroviral treatment with CD4 over 350/mm3 and plasma HIV RNA below 50 000/mL
- Ongoing Antiretroviral therapy at inclusion with CD4 over 450/mm3 and plasma HIV RNA below 5000/mL
Exclusion Criteria:
- HBV-HIV co-infection receiving lamivudine therapy
- Ongoing immunotherapy including IL2, interferon or HIV specific vaccine
- Pregnancy or project of pregnancy
Contacts and Locations| France | |
| Service d'immunologie Clinique, Höpital Européen Georges Pompidou | |
| Paris, France, 75015 | |
| Principal Investigator: | Christophe Piketti, MD | Hopital Georges Pompidou Paris France |
| Study Chair: | Dominique Costagliola | Inserm U720 |
More Information
No publications provided by French National Agency for Research on AIDS and Viral Hepatitis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00118677 History of Changes |
| Other Study ID Numbers: | ANRS 116 SALTO |
| Study First Received: | July 1, 2005 |
| Last Updated: | August 29, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV Infections |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013