Inclusion Criteria:1 HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
2 ART for at least 6 months prior to study entry with a regimen that includes enfuvirtide.
3 Self-defined infusion site reaction to enfuvirtide (usually will be painful inflammatory nodules) 4 No change in ART regimen for at least 3 months prior to study entry. 5 CD4+ cell count ≥50/mm3 at screening (obtained within 60 days prior to study entry).
6 Documentation of HIV-1 RNA below the limit of quantification of an ultrasensitive assay (for example, <50 copies/mL on Roche Amplicor HIV-1 Monitor Test or viral load<75 copies/mL on a bDNA assay), for a period of at least 6 months before study entry, verified by at least two measurements separated from each other by at least 60 days. The first measurement must be performed at least 3 months prior to study entry, and the second measurement must be performed within 60 days prior to study entry (the measurement obtained at the time of screening may be used to fulfill this criterion). Patients with a viral load > 50 copies, but less than 200 copies within the 6 month prior to entry will be eligible as long as the viral loads prior to and after the dectectable viral load are < 50 copies.
7 All HIV-1 RNA levels obtained within 6 months prior to study entry are below the limits of quantification on all tests, except as explained above in section 4.1.6 for a single dectable viral load of <50 copies but <200 copies in last 6 months.
8 Laboratory values obtained within 60 days prior to entry:
- Absolute neutrophil count (ANC) >750/mm3
- Hemoglobin >9.0 g/dL for female subjects and>10.0 g/dL for male subjects
- Platelet count >50,000/mm3
- Calculated creatinine clearance (CrCl) >30 mL/min, as estimated by the Cockcroft-Gault equation*
NOTE: *Calculation for the Cockcroft-Gault equation is available at https://www.fstrf.org/apps/cfmx/apps/common/Portal/index.cfm
- AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN
Total bilirubin <2.5 x ULN. If the subject is taking an indinavir- or atazanavir-containing regimen at the time of screening, total bilirubin ≤5 x ULN is acceptable.
9 For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation), will need a negative serum or urine pregnancy test within 48 hours prior to entry.
NOTE: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, vasectomy, and menopause is subject-reported history.
10 All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/ partner must use at least two reliable methods of contraception, (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormonal based contraception), while receiving study treatment and for 6 weeks after stopping study treatment.
11 Men and women age >18 years. 12 Ability and willingness of subject to provide informed consent.
 Exclusion Criteria:1 Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
2 Breast-feeding or pregnancy. 3 An opportunistic infection within 60 days prior to entry. 4 Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
5 Active drug or alcohol use or dependence that, in the opinion of the Protocol Director, would interfere with adherence to study requirements.
6 Receipt of a non-HIV vaccination within 30 days prior to study entry or plan for receipt of vaccination during the study.
7 Plan to change the background ART within 24 weeks after study entry.
Purpose
