2nd National Conference Human Retroviruses and Related Infections Washington, DC - January 29 - February 2, 1995

Natl Conf Hum Retrovir Relat Infect 1995 Jan 29-Feb 2;2: (abstract no. 6)

Parent D, Ellner J, Hafner R, Williams M, Jacobs P, Hojczyk P, and ACTG 135 Protocol Team
George Washington Univ., Washington DC; Case Western Res. Univ., Cleveland, OH, and NIH, Bethesda, MD

79 symptomatic HIV-infected PTS with MA infection were enrolled in a Phase II/III study of RIF 600 mg/d, CIPRO 500 mg bid, CLOF 100 mg/d ETH 15mg/kg/d±AK 10 mg/kg/d × 4 wks. After a 1-2 wk observation period, 37 PTS were randomized to receive AK, 37 to the non-AK arm, and 5 were not randomized. Baseline characteristics were comparable: median CD4=10, median Kamovsky score=70. The median duration of RX was 12 wks w/median followup of 23 wks. PTS were classified as complete or partial responders on the basis of decreases in clinical symptoms of fever, diarrhea, and antipyretic use after 4, 8, and 12 wks of RX. At 4 wks, 33% of PTS randomized to AK had a complete or partial response vs 35% in the non-AK arm (Fisher's exact test=0.65); at 8 wks 62% vs 65% (p=0.70). Although there was no significant difference between groups, overall the mean proportion of febrile days decreased from 74% to 43% (p<0.001) at 4 wks, 24% at 8 wks. The mean proportion of days of antipyretic use decreased from 68% to 49% (p<0.001) at 4 wks, 31% at 8 wks. Quantitative cultures showed no significant difference between the AK and non-AK arms in the decrease in mean log₁₀ CFU relative to baseline at any visit, but the overall decline among all PTS relative to baseline was significant at 4 and 12 weeks of RX. Mean log₁₀ CFU for AK and non-AK arms were 2.11 and 1.70 at baseline 1.53 and 0.99 after 4 wks, and 0.47 and 0.62 after 12 wks. The proportion of negative cultures increased in similar fashion. 13 PTS died within the first 12 wks, 24 during the remainder of study, 10 after study discontinuation. There was no difference between RX arms in after study discontinuation. There no was difference between RX arms in survival distributions (logrank test p=0.83). The addition to AK to this four-drug oral regimen did not provide additional clinical or microbiological benefit.

Keywords: AIDS Vaccines, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Amikacin, Bacteremia, Ciprofloxacin, Clinical Trials, Clofazimine, Communicable Diseases, Drug Therapy, Combination, Ethambutol, HIV Seropositivity, Humans, Infection, Mycobacterium avium, Mycobacterium avium Complex, Mycobacterium avium-intracellulare Infection, Physical Therapy Modalities, Rifampin, drug therapy, therapy

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1995-01-29
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