Status:
TERMINATED
Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Schering-Plough
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether the adjunctional of interferon alfa to structured treatment interruptions correlated with a long time off treatment in HIV-1 infection.
Detailed Description
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 interr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00125814
Start Date
December 1 2001
End Date
January 1 2005
Last Update
August 16 2005
Active Locations (1)
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1
Service de Medecine Interne
Clamart, France, 92140