A Double-Blind, Adjuvant-Controlled Trial of Human Immunodeficiency Virus Type 1 (HIV-1) Immunogen (Remune) Monotherapy in Asymptomatic, HIV-1-Infected Thai Subjects with CD4-Cell Counts of >300

ABSTRACT We examined the effect of a human immunodeficiency virus (HIV)-specific immune-based therapy in Thailand, where access to antiviral drug therapy is limited. A 40-week trial was conducted with 297 asymptomatic, HIV-infected Thai subjects with CD4-cell counts greater than 300 μl/mm 3 . Subjects were randomized to receive either HIV type 1 (HIV-1) immunogen (Remune; inactivated HIV-1 from which gp120 is depleted in incomplete Freund's adjuvant or adjuvant control at 0, 12, 24, and 36 weeks at five different clinical sites in Thailand. Neither group received antiviral drug therapy. The a priori primary endpoint for the trial was changes in CD4-cell counts with secondary parameters of percent changes in CD8-cell counts (percent CD4, CD8, and CD4/CD8) and body weight. Subsets of subjects were also examined for changes in plasma HIV-1 RNA levels, Western blot immunoreactivity, and HIV-1 delayed-type hypersensitivity (DTH) skin test reactivity. There was a significant difference in changes in CD4-cell counts that favored the HIV-1 immunogen-treated group compared to those for the adjuvant-treated control group ( P &lt; 0.05). On average, for HIV-1 immunogen-treated subjects CD4-cell counts increased by 84 cells by week 40, whereas the increase for the control group was 38 cells by week 40. This increase in CD4-cell count was associated with increased HIV-specific immunogenicity, as shown by Western blotting and enhanced HIV-1 DTH skin reactivity. No significant differences in adverse events were observed between the groups. The results of this trial suggest that HIV-1 immunogen is safe and significantly increases CD4-cell counts and HIV-specific immunity compared to those achieved with the adjuvant control in asymptomatic HIV-1-infected subjects not taking antiviral drugs. </jats:p

Efficacy of Structural-Level Condom Distribution Interventions: A Meta-Analysis of U.S. and International Studies, 1998–2007

This systematic review examines the overall efficacy of U.S. and international-based structural-level condom distribution interventions (SLCDIs) on HIV risk behaviors and STIs and identifies factors associated with intervention efficacy. A comprehensive literature search of studies published from January 1988 through September 2007 yielded 21 relevant studies. Significant intervention effects were found for the following outcomes: condom use, condom acquisition/condom carrying, delayed sexual initiation among youth, and reduced incident STIs. The stratified analyses for condom use indicated that interventions were efficacious for various groups (e.g., youth, adults, males, commercial sex workers, clinic populations, and populations in areas with high STI incidence). Interventions increasing the availability of or accessibility to condoms or including additional individual, small-group or community-level components along with condom distribution were shown to be efficacious in increasing condom use behaviors. This review suggests that SLCDIs provide an efficacious means of HIV/STI prevention

Evaluating HIV/STD interventions in developing countries: do current indicators do justice to advances in intervention approaches?

HIV continues to spread unabated in many developing countries. Here we consider the interventions that are currently in place and critically discuss the methods that are being used to evaluate them as reported in the published literature. In recent years there has been a move away from highly individual-oriented interventions towards more participatory approaches that emphasise techniques such as community-led peer education and group discussions. However, this move towards more community orientated intervention techniques has not been matched by the development of evaluation methods with which to capture and explain the community and social changes which are often necessary preconditions for health-enhancing behaviour change. Evaluation research continues to rely on quantitative methodologies that fail to elucidate the complex changes that the newer interventions seek to promote within target communities. In addition, these methods of evaluation tend to rely on the use of highly individualistic and quantitative biomedical indicators such as HIV/STD rates, or knowledge, attitude, perception and behaviour (KAPB) survey questionnaires. We argue that such approaches are inadequate for the task of tracking and measuring important determinants of programme success such as psycho-social changes, features of the community-intervention interface and the degree of trust and identification with which members of target communities regard particular interventions. Rigorously conducted qualitative process evaluations taking account of the above factors could make a key contribution to the development of more successful HIV-prevention interventions