Yarchoan R, Nguyen BY, Wyvill KM, Venzon DJ, Pluda JM, Mitsuya H, Broder S; International Conference on AIDS.
Int Conf AIDS. 1994 Aug 7-12; 10: 17 (abstract no. 360B).
NCI, NIH, Bethesda, MD 20892.
OBJECTIVE: To analyze the long-term course and assess predictors of survival in pts with advanced HIV infection entered on an escalating dose phase-I study of ddI. METHODS: 72 pts were entered onto a study of ddI starting in July, 1988. Some were later given the option of switching to combination AZT/ddI. The cohort was followed until July, 1994. Follow-up is available on all pts who entered. RESULTS: All pts had < 400 CD4 cells/mm3 at entry (median 50 CD4 cells/mm3); 29 pts had AIDS at entry. For pts who entered prior to a diagnosis of AIDS, the median time to AIDS or death was 28 months (95% CI 17-41 mos). The median survival for all pts was 28 mos (95% CI 23-46 mos). Baseline CD4 counts, CD8 counts, hemoglobin, lymphocytes, sedimentation rates, a diagnosis of AIDS, and fever were (in decreasing order) predictive of survival. CD4 increases above baseline at 3 mos and 1 yr were significant predictors of survival when a correction was made for entry CD4 count. Pts who entered with 100-300 CD4 cells/mm3 had an estimated 80% survival after 4 yr. CD4 counts were sustained above baseline for 3 yrs in 5/16 evaluable pts who entered with 100-300 CD4 cells/mm3. Major toxicities were pancreatitis (6 pts) and peripheral neuropathy (11 pts). DISCUSSION AND CONCLUSIONS: Therapy with ddI can be tolerated for more than 4 yr in some pts and may have particular long-term utility in pts with moderately advanced immunosuppression (100-300 CD4 cells/mm3).
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- CD4 Lymphocyte Count
- CD4-Positive T-Lymphocytes
- Clinical Trials, Phase I as Topic
- Didanosine
- HIV Infections
- Humans
- Peripheral Nervous System Diseases
- Zidovudine
Other ID:
UI: 102210131
From Meeting Abstracts