HIV Infections
Conditions
Keywords
HIV infections
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 in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection.
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 in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy (IT) strategy (8 weeks off / 8 weeks on) to a continuous treatment (CT) in patients with chronic and well controlled HIV-1 infection (CD4 over 450/µl and plasma HIV1-RNA below 200 cp/ml) under HAART, over a 96-week study period. The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300/µl. It will compare the proportions of and time to immunological failure (CD4 count below 300/µl confirmed by a retest 14 days later) in the IT and CT groups.
Interventions
PROCEDUREIntermittent antiretroviral therapy
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients with CD4 count over 450/µl at week 96 | — |
| Proportions of patients with plasma HIV load over 400 and 1000/ml thresholds | — |
| Plasma and peripheral blood mononuclear cells (PBMC) HIV resistance patterns | — |
| Proportions of patients withdrawing initial treatment strategy | — |
| 1993 Centers for Disease Control (CDC) classification of HIV infection B or C events | — |
| Antiretroviral therapy (ARTs) adherence assessment | — |
| Quality of life assessment | — |
| Cost impact of the strategies | — |
| Assessment of lipodystrophy and metabolic abnormalities | — |
Countries
France
Outcome results
None listed