Abstract
We conducted a three-arm, randomized, phase II study to evaluate the combination of zidovudine (600 mg/day) and zalcitabine (2.25 mg/day) alone or with one of two interferon-α(2a) doses (1 mIU or 6 mIU daily). Primary study endpoints included toxicity and changes from baseline for plasma HIV-1 RNA, CD4 cells, and quantitative microculture at weeks 8 and 24. Sixty-three patients with HIV infection and <400 CD4 cells/mm3 were enrolled; four patients discontinued therapy within 2 weeks. Adverse event rates were 37%, 32%, and 60%, respectively, for the nucleoside, 1-mIU interferon, and 6-mIU interferon combination groups. Increasing doses of interferon resulted in significantly greater hematologic toxicity (p = 0.03) and peripheral neuropathy (p = 0.02). Plasma HIV-1 RNA reductions were noted across all treatment groups at week 8 (p < 0.001) but only for the nucleoside and 1-mIU interferon combination groups at week 24 (p < 0.001). Mean reductions in HIV- 1 RNA at week 8 were 0.94, 1.29, and 1.40 log10, respectively, for the nucleoside, 1-mIU interferon, and 6-mIU interferon combination groups (p = 0.05); no differences were noted at week 24. No differences in CD4 cell counts were seen. The addition of interferon-α(2a) to zidovudine and zalcitabine resulted in transient enhanced decreases in viral load and increased toxicity.
| Original language | English |
|---|---|
| Pages (from-to) | 247-253 |
| Number of pages | 7 |
| Journal | Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology |
| Volume | 16 |
| Issue number | 4 |
| State | Published - Dec 22 1997 |
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Keywords
- Combination therapy
- HIV infection
- Interferon
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Virology
Cite this
Safety and antiviral activity of combination therapy with zidovudine, zalcitabine, and two doses of interferon-α(2a) in patients with HIV : AIDS Clinicals Trials Group Study 197. / Fischl, Margaret A; Richman, D. D.; Saag, M.; Tze Chiang Meng, Chiang Meng; Squires, K. E.; Holden- Wiltse, J.; Meehan, P. M.
In: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, Vol. 16, No. 4, 22.12.1997, p. 247-253.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and antiviral activity of combination therapy with zidovudine, zalcitabine, and two doses of interferon-α(2a) in patients with HIV
T2 - AIDS Clinicals Trials Group Study 197
AU - Fischl, Margaret A
AU - Richman, D. D.
AU - Saag, M.
AU - Tze Chiang Meng, Chiang Meng
AU - Squires, K. E.
AU - Holden- Wiltse, J.
AU - Meehan, P. M.
PY - 1997/12/22
Y1 - 1997/12/22
N2 - We conducted a three-arm, randomized, phase II study to evaluate the combination of zidovudine (600 mg/day) and zalcitabine (2.25 mg/day) alone or with one of two interferon-α(2a) doses (1 mIU or 6 mIU daily). Primary study endpoints included toxicity and changes from baseline for plasma HIV-1 RNA, CD4 cells, and quantitative microculture at weeks 8 and 24. Sixty-three patients with HIV infection and <400 CD4 cells/mm3 were enrolled; four patients discontinued therapy within 2 weeks. Adverse event rates were 37%, 32%, and 60%, respectively, for the nucleoside, 1-mIU interferon, and 6-mIU interferon combination groups. Increasing doses of interferon resulted in significantly greater hematologic toxicity (p = 0.03) and peripheral neuropathy (p = 0.02). Plasma HIV-1 RNA reductions were noted across all treatment groups at week 8 (p < 0.001) but only for the nucleoside and 1-mIU interferon combination groups at week 24 (p < 0.001). Mean reductions in HIV- 1 RNA at week 8 were 0.94, 1.29, and 1.40 log10, respectively, for the nucleoside, 1-mIU interferon, and 6-mIU interferon combination groups (p = 0.05); no differences were noted at week 24. No differences in CD4 cell counts were seen. The addition of interferon-α(2a) to zidovudine and zalcitabine resulted in transient enhanced decreases in viral load and increased toxicity.
AB - We conducted a three-arm, randomized, phase II study to evaluate the combination of zidovudine (600 mg/day) and zalcitabine (2.25 mg/day) alone or with one of two interferon-α(2a) doses (1 mIU or 6 mIU daily). Primary study endpoints included toxicity and changes from baseline for plasma HIV-1 RNA, CD4 cells, and quantitative microculture at weeks 8 and 24. Sixty-three patients with HIV infection and <400 CD4 cells/mm3 were enrolled; four patients discontinued therapy within 2 weeks. Adverse event rates were 37%, 32%, and 60%, respectively, for the nucleoside, 1-mIU interferon, and 6-mIU interferon combination groups. Increasing doses of interferon resulted in significantly greater hematologic toxicity (p = 0.03) and peripheral neuropathy (p = 0.02). Plasma HIV-1 RNA reductions were noted across all treatment groups at week 8 (p < 0.001) but only for the nucleoside and 1-mIU interferon combination groups at week 24 (p < 0.001). Mean reductions in HIV- 1 RNA at week 8 were 0.94, 1.29, and 1.40 log10, respectively, for the nucleoside, 1-mIU interferon, and 6-mIU interferon combination groups (p = 0.05); no differences were noted at week 24. No differences in CD4 cell counts were seen. The addition of interferon-α(2a) to zidovudine and zalcitabine resulted in transient enhanced decreases in viral load and increased toxicity.
KW - Combination therapy
KW - HIV infection
KW - Interferon
UR - http://www.scopus.com/inward/record.url?scp=0030734519&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0030734519&partnerID=8YFLogxK
M3 - Article
C2 - 9402071
AN - SCOPUS:0030734519
VL - 16
SP - 247
EP - 253
JO - Journal of acquired immune deficiency syndromes (1999)
JF - Journal of acquired immune deficiency syndromes (1999)
SN - 1525-4135
IS - 4
ER -