Publications

In the United States, men who have sex with men (MSM) currently represent more than 50% of those living with HIV and over 70% of HIV+ men (CDC 2007, http://www.cdc.gov/hiv/topics/msm/resources/factsheets/pdf/msm.pdf ). Male-to-male sexual contact has been identified as the predominant route of transmission among this sub-group, which underscores the need for research that targets risk factors associated with risky sex-related HIV acquisition. Along these lines, research has shown that one potentially important predictor variable for risky sex among MSM is alcohol use. The major aim of this paper is to review and integrate empirical evidence on the association of alcohol use and risky sex among MSM. A summary of the quantitative research is provided first, followed by a critique of the reviewed literature, a discussion of the consistency of the existing empirical evidence with predictions of current theories, and finally, recommendations for future research designed to evaluate alcohol-related sexual risk in MSM.

We recommend that regulatory agencies add the extent of drug metabolism (i.e., >or=90% metabolized) as an alternate method in defining Class 1 marketed drugs suitable for a waiver of in vivo studies of bioequivalence. That is, >or=90% metabolized is an additional methodology that may be substituted for >or=90% absorbed. We propose that the following criteria be used to define>or=90% metabolized for marketed drugs: Following a single oral dose to humans, administered at the highest dose strength, mass balance of the Phase 1 oxidative and Phase 2 conjugative drug metabolites in the urine and feces, measured either as unlabeled, radioactive labeled or nonradioactive labeled substances, account for >or=90% of the drug dosed. This is the strictest definition for a waiver based on metabolism. For an orally administered drug to be >or=90% metabolized by Phase 1 oxidative and Phase 2 conjugative processes, it is obvious that the drug must be absorbed. This proposal, which strictly conforms to the present>or=90% criteria, is a suggested modification to facilitate a number of marketed drugs being appropriately assigned to Class 1.

OBJECTIVE

To determine the prevalence of illicit drug use and the impact on HIV treatment.

DESIGN

Multivariable regression of cross-sectional data from 1163 HIV-infected and 294 controls from the Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM).

METHODS

An analysis of (1) prevalence of specific illicit drug use (ever, current), (2) being on HAART among those with an indication and (3) current HIV RNA and CD4 cell count among HAART users.

RESULTS

Median age was 42 years, approximately 50% were non-Caucasian and 33% were women. Eighty-six percent of HIV-infected and 67% of controls reported ever using illicit drugs (P < 0.0001); 28% of HIV-infected and 16% of controls reported current use (P = 0.0001). In adjusted models, current cocaine use and past heroin use were associated with not currently being on HAART. Among HAART users, those reporting past heroin use were as likely to have an undetectable HIV viral load as those who had never used heroin. Current and past cocaine use and current heroin use was associated with lower odds of undetectable HIV RNA. Past amphetamine use was associated with having an undetectable HIV. Similar results were seen for CD4 lymphocyte counts.

CONCLUSION

Illicit drug use in the US is common, although far fewer report current use than past use. Among HIV-infected patients, understanding of the type of illicit drugs used and whether drug use was in the past or ongoing is important, because of their differential effects on HIV treatment outcomes.