ABSTRACT
Progressive Multifocal Leukoencephalopathy (PML) is an opportunistic infection of the brain in advanced stages of AIDS. PML is caused by the JC virus, which leads to a decline in mental acuity and motor functions over a period of weeks or months. Currently, there is no treatment or cure for PML. Cidofovir, an antiviral agent, at the standard dosages for the treatment of cytomegalovirus (CMV) was implemented in the treatment and management of a 35-year-old, newly diagnosed AIDS, White male with PML. The patient presented with impaired motor functions of the left upper and lower extremities, which resulted in hemiparalysis and hemiparesis. The use of cidofovir infusions at standard recommendations for treatment and management of CMV has resulted in improvement and some resolution of the patient's paralysis and paresthesia. The patient has remained on the cidofovir for more than a year, with no signs of advancement of his PML or AIDS. Further investigation and extensive clinical trials are needed in the treatment and management of PML with the use of cidofovir.
Subject(s)
AIDS-Related Opportunistic Infections/drug therapy , Antiviral Agents/therapeutic use , Cytosine/analogs & derivatives , Leukoencephalopathy, Progressive Multifocal/drug therapy , Organophosphonates , Organophosphorus Compounds/therapeutic use , Adult , Cidofovir , Clinical Protocols , Cytosine/therapeutic use , Drug Administration Schedule , Humans , Longitudinal Studies , Male , Treatment OutcomeABSTRACT
Administration of didanosine (ddI) as buffered tablets is complicated by its poor palatability. The tolerance and palatability of pediatric powder ddI in an adult population of subjects with HIV infection as compared with buffered ddI tablets was compared. Twenty HIV-infected, were enrolled in a randomized crossover trial. Subjects took one of the two randomly assigned formulations for 4 weeks and then were crossed over to the alternative treatment. Twenty subjects were enrolled, and all of them completed the study. Of the 16 subjects, 10 reported that taking the ddI tablets affected the quality of their lives negatively. Of the participants, 18 (905) rated the pediatric formulation as 6 (better) or 2 (much better) than the buffered tablets. Preference was based on better taste and ease to swallow, although none of these 18 patients reported difficulties taking the pediatric formulation. In contrast, 19 of the 20 subjects reported difficulties taking the buffered tablets during the study period, including poor taste, trouble swallowing them, and diarrhea. Tolerance and palatability of ddI demonstrate marked improvement by the use of the pediatric powder, which suggests that the administration of ddI can markedly enhanced by the use of pediatric formulation.
Subject(s)
Anti-HIV Agents/administration & dosage , Anti-HIV Agents/adverse effects , Didanosine/administration & dosage , Didanosine/adverse effects , Digestive System/drug effects , HIV Infections/drug therapy , HIV Infections/nursing , Administration, Oral , Adult , Chemistry, Pharmaceutical , Cross-Over Studies , Female , Humans , MaleABSTRACT
OBJECTIVE: To evaluate the safety and immunogenicity of a polyvalent (PV) HIV envelope synthetic peptide immunogen, C4-V3. The immunogen comprised four peptides containing T-helper epitopes from the fourth constant region (C4) of gp120 of HIV-1MN, and T-helper, cytotoxic T-lymphocyte HLA-B7-restricted, and B-cell neutralizing epitopes from the gp120 third variable region (V3) of four clade B HIV-1 isolates, HIV-1MN, HIV-1RF, HIV-1EV91, and HIV-1Can0A. DESIGN: A pilot, Phase I controlled trial [Division of AIDS Treatment Research Initiative (DATRI) 010] conducted at a single center. METHODS: Ten HIV-infected, HLA-B7-positive patients with CD4 cells > 500 x 10(6)/l were enrolled. Eight patients received the C4-V3 PV immunogen emulsified in incomplete Freund's adjuvant in five intramuscular injections over 24 weeks, and two controls received incomplete Freund's adjuvant alone. All subjects were followed for 52 weeks. RESULTS: Four out of eight C4-V3 PV recipients generated at least fourfold rise in serum antibody titers to at least three immunogen peptides in contrast to none of the control subjects. Four out of eight C4-V3 PV recipients and none of the controls had an at least fourfold rise in neutralizing antibodies to either HIV-1MN, HIV-1RF, or HIV-1(4489-5) laboratory-adapted HIV isolates. 3H-Thymidine incorporation assays of peripheral blood mononuclear cells increased at least fivefold over the baseline stimulation index to at least one of the immunogen peptides in two consecutive post-immunization timepoints in five out of eight C4-V3 PV recipients versus none of the controls. CD4 cell counts and plasma HIV RNA levels did not change in patients who received either C4-V3 PV or adjuvant alone. Adverse events consisted primarily of grade 1 injection site reactions in six subjects (four C4-V3 recipients, two controls). CONCLUSIONS: C4-V3 PV synthetic peptides demonstrated both immunogenicity and safety in HIV-infected patients.
Subject(s)
AIDS Vaccines/immunology , HIV Envelope Protein gp120/immunology , HIV Infections/prevention & control , HLA-B7 Antigen/immunology , Vaccines, Synthetic/immunology , AIDS Vaccines/adverse effects , Adult , Amino Acid Sequence , Antigens, CD/analysis , Cell Line, Transformed , Enzyme-Linked Immunosorbent Assay , Female , HIV Antibodies/blood , HIV Envelope Protein gp120/adverse effects , HIV Infections/immunology , HIV Infections/virology , Humans , Intradermal Tests , Lymphocyte Subsets/immunology , Lymphocytes/immunology , Male , Middle Aged , Molecular Sequence Data , Neutralization Tests , Pilot Projects , RNA, Viral/blood , T-Lymphocytes, Cytotoxic/immunology , Vaccines, Synthetic/adverse effectsABSTRACT
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