Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals

Exclusion Criteria

• •Chronic hepatitis B, as evidenced by a positive test for hepatitis B surface antigen (HBsAg), an isolated positive Hepatitis B core antibody (negative HBsAg and anti-HBV Ab) and/or positive Hepatitis B virus (HBV) DNA.
• •Chronic hepatitis C virus (HCV) infection as evidenced by a positive test for HCV RNA. Subjects with a positive test for HCV antibody and a negative test for HCV RNA are eligible.
• •Has a history of institution of ART within 12 weeks of being diagnosed with acute or early HIV-1, where acute/early infection is defined by any one of the following:
• •* Positive HIV-1 enzyme immunoassay (EIA) with negative/indeterminate HIV-1 western blot that subsequently becomes positive
• •* Negative HIV-1 EIA within the past 4 months and HIV-1 RNA levels of greater than 400,000 copies/mL, in the setting of a potential exposure to HIV-1.
• •* Negative rapid HIV-1 within one month prior to a positive HIV-1 EIA and HIV-1 western blot
• •* Low level HIV antibodies (positive EIA or western blot) with a non-reactive detuned EIA
• •Documented nadir CD4+ T cell count less than 200 cells /mm\^3
• •--Patients with a nadir CD4+ T cell count between 100-200 are not excluded, provided their current CD4+ T cell count has been \>450 the past 3 years
• •---Subjects with dips (i.e., transient decreases in their CD4 count) prior to screening may be included provided they satisfy the following criteria:
• •* a. The dips are \> 350 cells/mL, and
• •* b. Succeeding CD4 counts return to levels above 450 cells/mL on subsequent testing
• •Any history of AIDS defining opportunistic infections
• •Subjects with history of receiving ART consisting of mono or dual drug therapy
• •Documented multiclass antiretroviral drug resistance that, in the judgement of the investigator, would pose a risk of virologic failure should additional mutations develop during the study
• •Any experimental non-HIV vaccination received within 2 weeks prior to study enrollment and at any time during the study.
• •Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment/Day 0
• •Receipt of other investigational study agent within 28 days of enrollment/day 0 and at any time during the study
• •Any active malignancy that may require systemic chemotherapy or radiation therapy
• •Systemic immunosuppressive medications received within 3 months prior to enrollment. The following are not excluded: (1)corticosteroid nasal spray or inhaler; (2) topical corticosteroids for mild, uncomplicated dermatitis; and (3) oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy less than or equal to 10 days, with completion in greater than or equal to 30 days prior to enrollment/day 0)
• •History of or other clinical evidence of:
• •* Significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction)
• •* Severe illness, malignancy, immunodeficiency other than HIV, active systemic infection other than HIV, or any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study
• •Active drug or alcohol abuse or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements
• •Both male and female subjects to remain completely abstinent of potentially reproductive sexual intercourse (e.g. due to a committed lifestyle) or to consistently use BOTH a barrier method with a spermicide (male or female condom) AND ALSO one of the below listed methods of birth control:
• •* Continuous/daily hormonal methods including oral contraceptive pills, patch, implant/injection, etc.
• •* Surgical sterilization of either partner, of sufficient duration to be effective, and NOT known to have failed.
• •* Intrauterine device.
• •Females of childbearing potential must not be breast-feeding, possibly or actually pregnant, must not have had unprotected intercourse for one month prior to enrollment , and must agree not to become pregnant beginning from enrollment in the study to at least 8 weeks after the end of analytical treatment interruption.