Status:
TERMINATED
Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline...
Detailed Description
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline...
Eligibility Criteria
Inclusion
- HIV-1 infection
- CD4 cell count over 450/µl for at least 6 months prior to screening
- Plasma HIV1-RNA below 200 cop/ml for at least 6 months prior to screening
- Stable and well tolerated ART for at least 6 months prior to screening
- Acceptable methods of contraception
- Patient able to comply with the protocol
- Informed consent signed prior to (or at) screening
Exclusion
- CD4 nadir below 100/µl
- Abacavir or nevirapine in the current ART
- Hepatitis B with 3-TC, adefovir or tenofovir current therapy
- Current or upcoming treatment with interferon for hepatitis B or C
- History of AIDS-defining event in the 18 months prior to screening
- Pregnancy or breast feeding
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00122551
Start Date
December 1 2001
End Date
April 1 2005
Last Update
August 1 2005
Active Locations (2)
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1
Service des Maladies Infectieuses
Paris, France, 75010
2
Service des Maladies Infectieuses et Tropicales Hopital Purpan
Toulouse, France, 31059