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BACKGROUNDRepeat chlamydia detection after treatment is common, and there is concern that treatment failure may be a cause. METHODSWithin a randomized trial, we established a prospective cohort of 600 participants with anogenital chlamydia diagnoses (200 each of women, heterosexual men, and men who have sex with men [MSM]). Participants were invited for repeat testing at 3 months and to complete a behavioral survey at 4 months. Positive samples were analyzed for organism DNA load and genovar. We estimated repeat chlamydia positivity, reinfection and treatment failure rates, and investigated the biological and behavioral factors associated with a repeat positive test. RESULTSA total of 290 participants (100 women, 89 heterosexual men, 101 MSM) were retested at 1 to 4 months, with 43 repeat positives, including 26 classed as reinfection and 9 as treatment failures. Comparing MSM with heterosexual men and women combined, repeat positivity was higher (20.8% vs 11.6%, P = 0.04), and treatment failure was higher (6.9% vs 1.1%, P = 0.01), but there was no difference in reinfection rates (11.9% vs 7.4%, P = 0.21). Among MSM, the odds of repeat positivity increased by 90% with each additional log organism load in the original specimen (baseline) (adjusted odds ratio, 1.9; 95% confidence interval, 1.1–3.2). Among heterosexuals, the odds of repeat positivity decreased by 10% with each additional week delay in being retested for chlamydia (adjusted odds ratio, 0.9; 95% confidence interval, 0.8–0.9). CONCLUSIONSPositive retests were more common among MSM than heterosexuals. Treatment failure was more common in MSM with rectal chlamydia, reinforcing concerns about azithromycin treatment failure.

In this phase 2, randomized, placebo-controlled trial of 111 patients who had Behçet's syndrome with oral ulcers, apremilast, an oral phosphodiesterase-4 inhibitor that modulates several inflammatory pathways, reduced the number of ulcers and pain from ulcers at 12 weeks. The mucocutaneous lesions of Behçet’s syndrome include oral ulcers, genital ulcers, and papulopustular and nodular lesions. Recurrent oral ulcers can be disabling and have a substantial effect on quality of life. The current first-line therapy for the mucocutaneous lesions of Behçet’s syndrome includes colchicine and topical agents (e.g., glucocorticoids). 1 The efficacy of colchicine has been debated. 2 – 4 For lesions that are resistant to these treatments, azathioprine, interferon-α, thalidomide, and tumor necrosis factor α (TNF-α) antagonists are prescribed. There remains a need for a safe and effective treatment, and any new drug that is effective against oral ulcers (the hallmark lesion . . .

Anogenital warts (AGWs) are a common therapeutic challenge. All therapies are associated with burning, pain, and frustrating high rate of recurrence. The search for a new alternative continues. Recently, a diterpene ester extracted from the Euphorbia peplus plant (ingenol mebutate [IM]) has been shown to possess activity against AGWs. This study aimed to compare and evaluate the therapeutic efficacy and safety of topical 0.05% ingenol gel with another herbal extract medication (topical 25% podophyllin solution) in treatment of AGWs. This was a comparative single blinded nonrandomized, 2-arm trial of ingenol 0.05% gel versus podophyllin solution 25% administered up to 6 times to patients with AGWs. To evaluate the therapeutic efficacy, the complete clearance rate and recurrence rate were assessed 1 and 12 weeks after last treatment, respectively. Safety was assessed by occurrence and severity of pain and local skin reaction (LSR). Of 31 and 36 patients in the IM group and podophyllin group who completed the study, initial complete resolution was observed in 20 (64.5%) and 14 (38.9%) patients, respectively (P = 0.03). The initial clearance was faster in the IM group (2.00 ± 0.91 weeks) compared with the podophyllin group (4.21 ± 1.05 weeks, P = 0.00). After 3 months, recurrence was seen in 13 (65.0%) of 20 patients in the IM group and 6 (42.8%) of 14 in the podophyllin group (P = 0.20). The number of patients with complete resolution after 3 months was not different between the 2 groups (7/31 in the IM group and 8/36 in the podophyllin group, P = 0.97). The mean ± SD severity scores for LSR and pain in the IM group were 6.65 ± 1.76 and 6.13 ± 2.57, respectively, which was significantly higher than their scores (3.39 ± 1.57 and 2.58 ± 1.38) in the podophyllin group (P = 0.00). Ingenol mebutate 0.05% gel is effective as podophyllin 25% solution in treating AGWs, with further benefit of being much more rapid. However, high recurrence rate, sever pain, and LSR limit its use.

Imiquimod, an immune response modifier, has been demonstrated to be safe and effective in the treatment of external genital and perianal warts caused by human papillomavirus (HPV). To identify the molecular mechanism(s) by which condylomata acuminata clear during topical treatment with imiquimod, wart skin biopsies were taken from patients before treatment, at treatment week 6, and at the end of treatment. Tissues were analyzed for HPV DNA and for mRNA of several cytokines and HPV gene products. Wart clearance was associated with evidence of tissue production of interferon-α, -β, and -γ and tumor necrosis factor-α. Regression of warts was strongly associated with a decrease in HPV DNA and in mRNA expression for both early and late viral proteins. Thus, topical imiquimod treatment of anogenital warts led to significant increases in local production of multiple interferon mRNAs and a significant reduction in virus load as measured by decreases in HPV DNA and mRNA for early HPV proteins.

Chancroid is a sexually transmitted disease (STD) caused by the Gram negative bacterium Haemophilus ducreyi and is characterised by necrotising genital ulceration which may be accompanied by inguinal lymphadenitis or bubo formation. H ducreyi is a fastidious organism which is difficult to culture from genital ulcer material. DNA amplification techniques have shown improved diagnostic sensitivity but are only performed in a few laboratories. The management of chancroid in the tropics tends to be undertaken in the context of syndromic management of genital ulcer disease and treatment is usually with erythromycin. A number of single dose regimens are also available to treat H ducreyi infection. Genital ulceration as a syndrome has been associated with increased transmission of human immunodeficiency virus (HIV) infection in several cross sectional and longitudinal studies. Effective and early treatment of genital ulceration is therefore an important part of any strategy to control the spread of HIV infection in tropical countries.

Background: Episodic acyclovir therapy has been added to genital ulcer disease (GUD) syndromic management guidelines in several sub-Saharan African countries with human immunodeficiency virus (HIV) epidemics. We examined the correlates of health care seeking in men with GUD and its relationship to HIV-1 and herpes simplex virus type 2 outcomes. Methods: Men with GUD (n = 615) were recruited from primary health care clinics in Gauteng province, South Africa for a randomized controlled trial of episodic acyclovir therapy. We used baseline survey and sexually transmitted infection/HIV-testing data to examine delay in health care seeking (defined as time from ulcer recognition to baseline study visit). Results: Median delay in health care seeking for GUD was 5 days, and one-quarter of men had previously sought care for the current ulcer. Previous care seekers were older, had more episodes of ulcération in the past year, and were more likely to test seropositive for HIV-1 and HSV-2. Delay in health care seeking was significantly associated with age, education level, and sex during the ulcération episode. Delays in care seeking were related to poorer HIV-1 outcomes; these findings were valid after controlling for advanced HIV. Conclusions: Interventions to help shorten the duration between ulcer recognition and health care seeking for men with GUD are needed.

By a randomised, double-blind, placebo-controlled trial of aciclovir 800 mg twice daily for 5 days added to the syndromic management of genital ulcer disease (GUD) to determine the impact on ulcer healing and HIV outcomes. Patients presenting with GUD in Malawi were evaluated for HIV and herpes simplex virus type-2 (HSV-2) serologies, ulcer aetiology, lesional, genital and plasma HIV-1 RNA and CD4+ count. Patients were followed up at days 2, 4, 7, 14 and 28. The primary study outcome was ulcer healing at day 14, with secondary outcomes being lesional and genital HIV-1 shedding at day 14 and HIV-1 plasma viral load at day 28 among HIV-1/HSV-2 co-infected individuals. Four hundred and twenty-two patients (74% male) were randomised (208 to aciclovir, 214 to placebo), of whom 61% were HIV-1 seropositive and 72% HSV-2 seropositive; 67% (267/398) had HSV-2 ulcers. 85% of ulcers were healed at day 14 with no difference between treatment arms (risk ratio (RR)=1.02, 95% CI 0.93 to 1.11). Among 244 HIV-1/HSV-2 co-infected individuals, aciclovir reduced lesional HIV-1 RNA (adjusted RR=0.64, 95% CI 0.41 to 0.99) and seminal HIV-1 RNA (adjusted RR=0.59, 95% CI 0.40 to 0.88), but not cervical HIV-1 RNA or plasma HIV-1 RNA. Episodic HSV treatment with aciclovir added to syndromic management did not produce a significant clinical benefit in this African population.

Background: Recurrent and painful genital ulcers are the hallmark of Behçet’s disease. Objective: To determine the efficacy of pimecrolimus (PIM) cream on the pain and healing time of genital ulcers. Methods: A total of 76 patients were randomized to either receive PIM cream plus colchicine (COL) tablets (1–2 g/day) or COL tablets (1–2 g/day) alone for 1 month. Clinical evaluations were performed in 68 patients at the baseline and on the 3rd, 7th, 10th, 14th and 28th days of treatment. Also, genital ulcer pain was evaluated using a verbal pain score at each visit. Safety was monitored through adverse event reporting and laboratory tests. Results: The mean healing time of genital ulcers was shorter in the PIM + COL group (4.2 ± 1.5 days) than the COL group (4.7 ± 1.8 days), without statistical significance (p = 0.399). Visual analog scale scores decreased in both groups significantly. Neither of the treatment modalities was found to be superior to the other; however, pain was relieved in 4.2 ± 0.5 days in PIM + COL group and in 5.5 ± 1.2 days in COL group in the intention to treat population (p = 0.023). Observed adverse events were transient. Conclusion: Compared to COL alone, COL + PIM cream shortens the pain duration without any significant effect on healing time.

Background The effect of IL-1 blocking therapy on mucocutaneous manifestations of Behçet’s disease is incompletely understood. Methods Six patients with Behçet’s disease and ongoing oral/genital ulcers for ≥1 month were enrolled into an adaptive, two-phase clinical trial and included in the analysis. Study duration was 6 months with extension up to 16 months. All were treated non-blinded with anakinra 100 mg subcutaneous daily with the option to escalate the dose to 200 mg in partial responders after 1 month and 300 mg after 6 months. Patients recorded the number and severity of ulcers in daily diaries. The primary outcome was remission defined as no ulcers on physical exam for two consecutive monthly visits between months 3 and 6. Secondary outcomes included the number and severity of patient-reported ulcers, patient/physician global scores, and standardized disease activity scores. Results Two of six patients achieved the primary outcome. Five of six patients had improvement in the number and severity of ulcers. Non-statistically significant improvements were seen in secondary outcomes. Over the entire study, patients reported ≥1 oral and ≥1 genital ulcer on 665 (66%) and 139 (14%) days, respectively. On anakinra 200 mg vs 100 mg, patients reported fewer days with oral ulcers (65% vs 74% of days, p  = 0.01) and genital ulcers (10% vs 22% of days, p  < 0.001) and milder oral ulcer severity ( p  < 0.001). Increase of anakinra to 300 mg did not result in further improvements. Adverse events were notable for mild infections. Conclusion Anakinra at an optimal dose of 200 mg daily had an acceptable safety profile and was partially effective in the treatment of resistant oral and genital ulcers in Behçet’s disease. Trial registration Clinicaltrials.gov. NCT01441076 . Registered on 24 September 2011.

Trichomonas vaginalis (TV) infection is the most prevalent curable sexually transmitted infection in the United States and worldwide. Most TV infections are asymptomatic, and the accurate diagnosis of this infection has been limited by lack of sufficiently sensitive and specific diagnostic tests, particularly for men. To provide updates for the 2010 Centers for Disease Control and Prevention's Sexually Transmitted Diseases Treatment Guidelines, a PubMed search was conducted of all TV literature published from 9 January 2004 through 24 September 2008. Approximately 175 pertinent abstracts and articles were reviewed and discussed with national experts. This article describes advances in TV diagnostics which have led to an improved understanding of the epidemiology of this pathogen, as well as potential biologic and epidemiological interactions between TV and human immunodeficiency virus (HIV). New data on treatment outcomes, metronidazole-resistant TV, management of nitroimidazole-allergic patients, frequency of recurrent TV infection following treatment, and screening considerations for TV in certain populations are also presented.