HIV antigen variability in ARC/AIDS.

Abstract

To define the natural variability of human immunodeficiency virus p24 antigen (HIV Ag) over time in untreated HIV-infected patients, we analyzed the percentage change of serum HIV Ag in 40 antigenemic ARC/AIDS subjects receiving placebo in a 24 week clinical trial. When grouped by month of observation, no differences in HIV Ag change were seen among all five 1 month observation periods (p greater than 0.4). After all 105 monthly changes (median of 3 per subject) were pooled, the mean monthly HIV Ag change was 0% change (standard deviation: 77% increase, 44% decrease). Furthermore, HIV Ag changes did not differ among all lengths of observation (from 1 to 5 months using all possible pairwise combinations of HIV Ag levels, p greater than 0.4). CD4 T-cell changes over the whole study did not correlate with HIV Ag changes over the same period. Knowledge of this broad HIV Ag variability should be useful in calculating sample size and in choosing categorical responses unlikely to occur spontaneously in clinical trials of antiviral agents where HIV Ag changes are used as surrogate markers of efficacy.

• Authors: C W Hendrix, P A Volberding, R E Chaisson
• Journal: Journal of acquired immune deficiency syndromes (J Acquir Immune Defic Syndr (1988)) Vol. 4 Issue 9 Pg. 847-50 ( 1991) ISSN: 0894-9255 [Print] United States
• PMID: 1910082 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Gene Products, gag
• HIV Antigens
• HIV Core Protein p24
• Placebos
• Viral Core Proteins
• Zidovudine

Topics

• AIDS-Related Complex (drug therapy, microbiology)
• Acquired Immunodeficiency Syndrome (drug therapy, microbiology)
• Double-Blind Method
• Follow-Up Studies
• Gene Products, gag (analysis)
• HIV Antigens (analysis)
• HIV Core Protein p24
• Humans
• Placebos
• Viral Core Proteins (analysis)
• Zidovudine (therapeutic use)