Blick G, Henry K, Greiger P, Kaplan S, Prasad B, Carey Z, Sasse R, Garton T, Hatton E, Groth K, Runne W, Kelly T, Sachs G, McCartney D, Westerbeck T; International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPeB3192.
G. Blick, Blick Medical Associates, 589 Bedford Street, Stamford, CT 06901, United States, Tel.: +1 203 357 7800, Fax: +1 203 357 7841, E-mail: blickmd@aol.com
Background: HIV is a heat-labile virus that may remain dormant in reservoirs for 60 years. Heat may upregulate and/or inactivate HIV. EWBH has been shown to be safe in individuals with HIV/AIDS. HIV is developing drug resistance and causing mitochondrial dysfunction. We are evaluating EWBH in individuals with HIV/AIDS off HAART. The results of the first 11 individuals are reported. Materials and Methods: We are evaluating EWBH in 40 patients who are failing HAART. Patients are randomized 1:1 to receive EWBH after discontinuing HAART (Treatment) or continue HAART until a 0.5 log increase in viral load (VL) is confirmed (Control). Retreatment with EWBH occurs after a 6-month follow-up period or if a 0.5 log increase in VL from nadir or baseline (BL) is confirmed. EWBH is performed using the PS-1 Temet device from First Circle Medical via percutaneous cannulation of bilateral femoral veins. Core body temperature is raised to 41.6-42.0C for 90 minutes. Results: TREATMENT: Five patients underwent EWBH. Complaints included fatigue, excitability, low-grade fever, and periorbital and facial edema for 1-3 days. Grades 3 and 4 thrombocytopenia and elevations in AST, ALT, and CPK occurred on Day(D)1 and resolved by Weeks 1-4. BL VL was 100,503. VL increased to 494,992 at D1, 356,037 at D3-7, and declined to 82,181 at Month(M)1 while remaining off HAART. CD4% and cell counts were stable at M2, and no retreatment criteria were reached. Quality-of-life (QOL) improved in 4/5 patients by M1-3. Control: By M3, endpoints were reached in 4/6 patients as 1 developed lymphoma at M2, and 3 experienced a confirmed 0.5 log increase in VL after a median 2 months. VL was 80,651 at BL and increased to 108,963 at M1 and 157,059 at M2 while remaining on HAART. CD4% declined from 7.6 to 5.8, while cell counts remained stable. QOL remained unchanged in 3/6 and worsened in 3/6 patients through M3. Conclusion: EWBH appears to be safe, and VL reductions and CD4 stability off HAART are encouraging.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Antigens, CD4
- Antiretroviral Therapy, Highly Active
- Clinical Trials as Topic
- Drug Therapy, Combination
- Fever
- HIV Infections
- HIV Seropositivity
- Humans
- Treatment Outcome
- Viral Load
- drug therapy
- immunology
- therapy
Other ID:
UI: 102239102
From Meeting Abstracts