A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy

R. B. Roberts, Gordon Dickinson, P. N R Heseltine, J. M. Leedom, P. W A Mansell, S. Rodriguez, K. M. Johnson, J. A. Lubina, R. W. Makuch, Margaret A Fischl

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Abstract

A double-blind, randomized, placebo-controlled trial comparing two daily doses of oral ribavirin and placebo was conducted at four medical centers. One hundred sixty-four adult men with lymphadenopathy were enrolled over a 2-month period and randomized to receive ribavirin 800 mg (53 subjects), ribavirin 600 mg (55 subjects), or placebo (56 subjects). Active treatment was administered for 24 weeks followed by a 4-week washout period. Nine subjects receiving placebo, four receiving ribavirin 600 mg, and none in the 800 mg group developed AIDS during the 24 weeks of active treatment. One patient randomized to the 800 mg group had Kaposi's sarcoma at study entry and was included in the intent-to-treat analysis. An overall significant difference in progression to AIDS was observed among the three treatment groups (p = 0.028) with patients randomized to receive 800 mg having a significantly longer time to AIDS than placebo patients (p = 0.012; relative risk, 9.0; 95% confidence interval, 1.1 to 70.8). There was no significant difference between the 600 mg and placebo groups (p = 0.15; relative risk, 2.3; 95% confidence interval, 0.7 to 7.6). Baseline CD4 cell count and hematocrit made independent contributions and formed a multivariate prognostic set for these progression data. The significant treatment superiority of 800 mg compared to placebo remained after adjustment for these factors (p = 0.019). After deletion of patients with major protocol violations at entry, the difference between the 800 mg and placebo treatment remained significant (p = 0.021). Reduction in CD4 counts was noted over the 24-week treatment period in both active treatment groups relative to placebo (600 mg vs. placebo, p = 0.018; 800 mg vs. placebo, p = 0.042). CD4 counts returned toward baseline levels in the two treatment groups during the subsequent 4-week washout period, while CD4 counts dropped during this same period in the placebo group. Functional lymphocyte measurements or delayed cutaneous hypersensitivity were not enhanced. Ribavirin was well tolerated and all clinical and hematologic adverse reactions were reversible following 24 weeks of active therapy.

Original languageEnglish
Pages (from-to)884-892
Number of pages9
JournalJournal of Acquired Immune Deficiency Syndromes
Volume3
Issue number9
StatePublished - Sep 17 1990

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Ribavirin
Multicenter Studies
Placebos
Clinical Trials
HIV
CD4 Lymphocyte Count
Acquired Immunodeficiency Syndrome
Therapeutics
Lymphadenopathy
Confidence Intervals
Kaposi's Sarcoma
Delayed Hypersensitivity
Hematocrit
Randomized Controlled Trials
Lymphocytes

ASJC Scopus subject areas

  • Immunology and Allergy
  • Virology

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A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. / Roberts, R. B.; Dickinson, Gordon; Heseltine, P. N R; Leedom, J. M.; Mansell, P. W A; Rodriguez, S.; Johnson, K. M.; Lubina, J. A.; Makuch, R. W.; Fischl, Margaret A.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 3, No. 9, 17.09.1990, p. 884-892.

Research output: Contribution to journalArticle

Roberts, RB, Dickinson, G, Heseltine, PNR, Leedom, JM, Mansell, PWA, Rodriguez, S, Johnson, KM, Lubina, JA, Makuch, RW & Fischl, MA 1990, 'A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy', Journal of Acquired Immune Deficiency Syndromes, vol. 3, no. 9, pp. 884-892.
Roberts, R. B. ; Dickinson, Gordon ; Heseltine, P. N R ; Leedom, J. M. ; Mansell, P. W A ; Rodriguez, S. ; Johnson, K. M. ; Lubina, J. A. ; Makuch, R. W. ; Fischl, Margaret A. / A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. In: Journal of Acquired Immune Deficiency Syndromes. 1990 ; Vol. 3, No. 9. pp. 884-892.
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abstract = "A double-blind, randomized, placebo-controlled trial comparing two daily doses of oral ribavirin and placebo was conducted at four medical centers. One hundred sixty-four adult men with lymphadenopathy were enrolled over a 2-month period and randomized to receive ribavirin 800 mg (53 subjects), ribavirin 600 mg (55 subjects), or placebo (56 subjects). Active treatment was administered for 24 weeks followed by a 4-week washout period. Nine subjects receiving placebo, four receiving ribavirin 600 mg, and none in the 800 mg group developed AIDS during the 24 weeks of active treatment. One patient randomized to the 800 mg group had Kaposi's sarcoma at study entry and was included in the intent-to-treat analysis. An overall significant difference in progression to AIDS was observed among the three treatment groups (p = 0.028) with patients randomized to receive 800 mg having a significantly longer time to AIDS than placebo patients (p = 0.012; relative risk, 9.0; 95{\%} confidence interval, 1.1 to 70.8). There was no significant difference between the 600 mg and placebo groups (p = 0.15; relative risk, 2.3; 95{\%} confidence interval, 0.7 to 7.6). Baseline CD4 cell count and hematocrit made independent contributions and formed a multivariate prognostic set for these progression data. The significant treatment superiority of 800 mg compared to placebo remained after adjustment for these factors (p = 0.019). After deletion of patients with major protocol violations at entry, the difference between the 800 mg and placebo treatment remained significant (p = 0.021). Reduction in CD4 counts was noted over the 24-week treatment period in both active treatment groups relative to placebo (600 mg vs. placebo, p = 0.018; 800 mg vs. placebo, p = 0.042). CD4 counts returned toward baseline levels in the two treatment groups during the subsequent 4-week washout period, while CD4 counts dropped during this same period in the placebo group. Functional lymphocyte measurements or delayed cutaneous hypersensitivity were not enhanced. Ribavirin was well tolerated and all clinical and hematologic adverse reactions were reversible following 24 weeks of active therapy.",
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