Kemper C, Haubrich R, Frank I, Buscarino C, McCutchan J, Deresinski S; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 8th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 8th 2001 Chic Ill. 2001 Feb 4-8; 8: 211 (abstract no. 558).
Santa Clara Valley Med Ctr, San Jose, CA.
Background: The purpose of this study was to assess the safety and immunogenicity of HVX in HAV-seronegative HIV+ patients. Methods: Following stratification based on CD4 cell count (<200, 200-499, >500/mm3), subjects were randomized to receive either HVX (1440 EL.U.) or placebo at 0 and 6 mos. Seroconversion frequency, geometric mean anti-HAV titers (GMT), CD4 cell counts, plasma HIV RNA, and adverse events were assessed post-vaccination at 1, 6, 6.5, 7, and 9 mos. Intent-to-treat analysis was performed in those receiving at least one dose. Antiretroviral therapy, which was unrestricted, was received by >90% of subjects in each group. Results: A total of 133 HAV-seronegative subjects were enrolled; 68 received HVX. Baseline characteristics were similar between groups. Seroconversion at mo. 9 was observed in 66.7% and 68.8% of those with CD4 counts >500 and 200-499/mm3 vs. only 9.1% with CD4 <200/mm3 (p =.004). GMTs were significantly higher among subjects with higher baseline CD4 counts. The only significant HVX- related adverse event was minor injection site soreness (approximately 35%). Increases in CD4 cell counts and decreases in HIV RNA levels were observed in both groups throughout the study. These changes were statistically significant at mo. 9 in placebo recipients but not in HVX recipients. However, ANOVA analyses showed that the differences in CD4 counts and HIV RNA were not statistically significant at any visit between treatment groups. Conclusions: 68% of subjects with CD4 counts >200/mm3 but only 9% of patients with lower CD4 counts responded to HVX. No effect from vaccination on HIV RNA was observed.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Blindness
- CD4 Lymphocyte Count
- Clinical Trials as Topic
- Disease Progression
- Double-Blind Method
- HIV Infections
- HIV Seropositivity
- Hepatitis A Antibodies
- Hepatitis A Vaccines
- Humans
- Placebos
- Safety
Other ID:
UI: 102244341
From Meeting Abstracts