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BackgroundThe genomic heterogeneity of HIV-1 impedes the ability of consensus sequences in vaccines to elicit effective antiviral immune responses. AGS-004 amplifies translation-competent RNA molecules encoding for Gag, Rev, Vpr, and Nef from the patient's autologous virus and loads them into dendritic cells.MethodsThis phase IIB, multicenter, 2:1 randomized, double-blind, placebo-controlled study enrolled 54 HIV-1-infected patients on antiretroviral therapy with viral loads (VLs) 450 cells per cubic millimeter, and nadir counts >200 cells per cubic millimeter, to receive intradermal injections of study product into the axillary lymph node region every 4 weeks. At week 16, a 12-week analytical treatment interruption (ATI) was undertaken.ResultsThere was no difference in the end-of-ATI VL (average of values from weeks 11 and 12) between the 2 arms of the study [4.39 (4.17, 4.69) vs. 4.47 (3.76, 4.64) log10 HIV-1 RNA; P = 0.73]. Between arms, no change between pre-antiretroviral therapy VL and the end-of-ATI VL [-0.06 (0.24, -0.32) vs. -0.17 (0.17, -0.32) log10 HIV-1 RNA; P = 0.43] was observed. When interferon-γ, interleukin-2, tumor necrosis factor α, CD107a, and granzyme b expressions were measured by multicolor flow cytometry, a greater percentage of AGS-004 than of placebo recipients had multifunctional cytotoxic T-lymphocyte responses induced in the CD28+/CD45RA-CD8 effector/memory T-cell population to dendritic cells electroporated with autologous antigens. Adverse events consisted of transient, mild (grade 1) local injection site reactions.ConclusionsDespite the induction of HIV-specific effector/memory CD8 T-cell responses, no antiviral effect was seen after the administration of AGS-004 when compared with placebo.

BackgroundThe genomic heterogeneity of HIV-1 impedes the ability of consensus sequences in vaccines to elicit effective antiviral immune responses. AGS-004 amplifies translation-competent RNA molecules encoding for Gag, Rev, Vpr, and Nef from the patient's autologous virus and loads them into dendritic cells.MethodsThis phase IIB, multicenter, 2:1 randomized, double-blind, placebo-controlled study enrolled 54 HIV-1-infected patients on antiretroviral therapy with viral loads (VLs) 450 cells per cubic millimeter, and nadir counts >200 cells per cubic millimeter, to receive intradermal injections of study product into the axillary lymph node region every 4 weeks. At week 16, a 12-week analytical treatment interruption (ATI) was undertaken.ResultsThere was no difference in the end-of-ATI VL (average of values from weeks 11 and 12) between the 2 arms of the study [4.39 (4.17, 4.69) vs. 4.47 (3.76, 4.64) log10 HIV-1 RNA; P = 0.73]. Between arms, no change between pre-antiretroviral therapy VL and the end-of-ATI VL [-0.06 (0.24, -0.32) vs. -0.17 (0.17, -0.32) log10 HIV-1 RNA; P = 0.43] was observed. When interferon-γ, interleukin-2, tumor necrosis factor α, CD107a, and granzyme b expressions were measured by multicolor flow cytometry, a greater percentage of AGS-004 than of placebo recipients had multifunctional cytotoxic T-lymphocyte responses induced in the CD28+/CD45RA-CD8 effector/memory T-cell population to dendritic cells electroporated with autologous antigens. Adverse events consisted of transient, mild (grade 1) local injection site reactions.ConclusionsDespite the induction of HIV-specific effector/memory CD8 T-cell responses, no antiviral effect was seen after the administration of AGS-004 when compared with placebo.

Describes Minnesota DARE (Drug Abuse Resistance Education) PLUS, a randomized trial of 24 schools and communities. During 1999-2001, students in eight schools will receive the DARE curriculum in 7th grade. Eight other schools will receive the curriculum plus additional parent involvement, peer leadership, and community components in 7th and 8th grades. Eight other schools will be controls. (SM)

Few behavioral interventions have been conducted to reduce high-risk sexual behavior among HIV-positive Men who have Sex with Men (HIV+ MSM). Hence, we lack well-proven interventions for this population. Positive Connections is a randomized controlled trial (n = 675 HIV+ MSM) comparing the effects of two sexual health seminars--for HIV+ MSM and all MSM--with a contrast prevention video arm. Baseline, 6-, 12- and 18-month follow-up surveys assessed psychosexual variables and frequency of serodiscordant unprotected anal intercourse (SDUAI). At post-test, intentions to avoid transmission were significantly higher in the sexual health arms. However, SDUAI frequency decreased equally across arms. HIV+ MSM engaging in SDUAI at baseline were more likely to leave the study. Tailoring interventions to HIV+ MSM did not increase their effectiveness in this study. A sexual health approach appeared as effective as an untailored video-based HIV prevention intervention in reducing SDUAI among HIV+ MSM. Keywords HIV+ MSM * MSM * HIV prevention * Behavioral interventions * Unsafe sex * Prevention for positives, Background Men who have Sex with Men (MSM) remain the largest population infected with HIV/AIDS in the United States. They comprise 48.1% of the 1.1 million adults and adolescents living [...]

Objectives. We assessed rates of childhood sexual abuse and its demographic and mental health correlates among HIV-positive men who reported unsafe anal intercourse with other men in the past year. Methods. We conducted a cross-sectional analysis of baseline data from 593 HIV-positive men who have sex with men enrolled in the Positive Connections intervention. Results. Childhood sexual abuse was reported by 47% of participants; 32% reported frequency as often or sometimes. Men reporting abuse were more likely to be Latino (odds ratio [OR = 2.6; 95% confidence interval [CI]=1.6, 4.2; P Conclusions. History of childhood sexual abuse is highly prevalent among HIV-positive men who engage in risky sexual behavior with other men and appears to be more common among men of color. Our findings suggest that abuse is associated with a significantly increased risk of sexually transmitted infections. doi: 10.2105/AJPH.2007.133280)

Objectives. We examined the prevalence and frequency of childhood sexual abuse and their association with sexual risk among a sample of gay and bisexual men. Methods. Cross-sectional data were collected by survey from randomly selected gay and bisexual men who attended the 1997 and 1998 Minneapolis/St. Paul Gay, Lesbian, Bisexual, and Transgender Pride Festivals. Data included demographics, sexual activity, history of childhood sexual abuse, HIV status, history of sexually transmitted infection, use of sex-related drugs (such as crack, cocaine, Ecstasy, amyl nitrate, crystal methamphetamine, and Special K), and history of exchanging sex for payment. Results. childhood sexual abuse was reported by 15.5% of the survey respondents (n = 134). Those who reported experiencing abuse regularly were more likely to (1) be HIV positive, (2) have exchanged sex for payment, and (3) be a current user of sex-related drugs. Neither unsafe sex nor sexually transmitted infections were associated with childhood sexual abuse. Conclusions. These findings show that more than 1 in 7 gay and bisexual men in a non-clinical, festival-based setting were victims of childhood sexual abuse and that childhood sexual abuse was associated with alarmingly high rates of men who were HIV infected and antecedent risk behaviors. doi:10.2105/AJPH.2005.071423

A repeated cross-section study report of antiretroviral resistance mutations to nucleoside reverse transcriptase inhibitors (NRTIs) and nonnucleoside reverse transcriptase inhibitors (NNRTIs) and of major mutations to protease inhibitors (PIs) in virus isolates from 300 HIV-infected pregnant women in New York City from 1991 to early 2001 is presented. The increasing prevalence of drug resistance in pregnant women, including those who are drug-naive, underscore the necessity for resistance testing to guide treatment to achieve suppression of the mother's virus.