No abstract

To obtain information on the prevalence of anovulation and early menopause and on pituitary-gonadal function among human immunodeficiency virus type 1-infected women, a study was undertaken that used stored serum samples from women aged 20-42 years who participated in selected Adult AIDS Clinical Trials Group protocols. Defined progesterone and follicle-stimulating hormone (FSH) levels were considered presumptive evidence of ovulation and of menopause, respectively. Anovulation occurred in 16 (48%) of 33 women for whom progesterone levels were tested; early menopause occurred in 2 (8%) of 24 women for whom FSH levels were tested. No statistically significant differences were seen in the demographic and clinical characteristics of anovulatory and ovulatory women, although women who ovulated had higher CD4 T cell counts and were less likely to have reported a recent change in menstrual periods. These data support the findings of prior studies of increased frequency of amenorrhea and/or irregular menstrual cycles, particularly among women with lower CD4 T cell counts.

The primary endpoint of AIDS prophylaxis trials is the occurrence of opportunistic infections. While the treatments are not expected to have an effect on the underlying HIV disease, an effect of treatments on mortality cannot be ruled out. Therefore, the primary analysis of these trials must be based on a combined endpoint of infection and survival times. There are several methods available for analysis of multiple failure time data. However, there is no standard method for combining mortality and other failures in these analyses. This paper explores the analysis of multiple infections in the context of a study in which treatments may have an effect on mortality. The methods are applied to an AIDS clinical trial of prophylaxis for fungal infections.

The primary endpoint of AIDS prophylaxis trials is the occurrence of opportunistic infections. While the treatments are not expected to have an effect on the underlying HIV disease, an effect of treatments on mortality cannot be ruled out. Therefore, the primary analysis of these trials must be based on a combined endpoint of infection and survival times. There are several methods available for analysis of multiple failure time data. However, there is no standard method for combining mortality and other failures in these analyses. This paper explores the analysis of multiple infections in the context of a study in which treatments may have an effect on mortality. The methods are applied to an AIDS clinical trial of prophylaxis for fungal infections.