A randomized, controlled, safety study using imiquimod for the topical treatment of anogenital warts in HIV-infected patients. Imiquimod Study Group.

OBJECTIVE: To assess the safety of imiquimod, an immune response modifier, in the topical treatment of external anogenital warts in HIV-infected patients. SETTING: Clinical sites in the United Kingdom (eight) and the United States (five). DESIGN: A prospective, randomized, double-blind, vehicle-controlled study of imiquimod 5% cream or vehicle applied for 8+/-2 h three times per week for a maximum of 16 weeks in HIV-seropositive males (n = 97) and females (n = 3) aged 18 years or more with clinically diagnosed external anogenital warts, CD4 T lymphocyte count of > or = 100 x 10(6) cells/l and Karnofsky score > or = 70. MAIN OUTCOME MEASURES: Safety was assessed through the incidence and severity of local skin reactions and other adverse events, and through clinical laboratory tests. Wart clearance was documented by two-dimensional measurements of warts and by photography. RESULTS: Among the patients treated with imiquimod (n = 65) and vehicle (n = 35), the most common local skin reaction was erythema, (41.9 and 26.7%, respectively) and the incidence of patients reporting at least one adverse event was 69.2 and 65.7%, respectively. No clinically meaningful differences or changes in laboratory values were observed between treatment groups, nor were drug-related adverse effects observed in regard to HIV disease. While there was no significant difference between treatment groups in the number of patients who totally cleared their baseline warts (imiquimod 11% versus vehicle 6%, P = 0.488), more imiquimod-treated patients experienced a > or = 50% reduction in baseline wart area (38% versus 14%, P = 0.013). CONCLUSION: Most local skin reactions were mild and no adverse effects on HIV disease were observed. Topically applied imiquimod 5% cream reduced wart area and may have clinical utility in treating external anogenital warts in some HIV-infected patients.

Greater emotional distress is associated with accelerated CD4+ cell decline in HIV infection.

An investigation was conducted to explore the relationship between emotional distress and HIV progression. One hundred twenty-five homosexual, HIV-positive males participated in a 12-month longitudinal investigation. Psychosocial data were collected at 6-month intervals and CD4+ data were collected from diagnosis to the end of the investigation. Principal component analyses were performed initially to identify factors of emotional distress and health status. In addition, CD4+ reliability assessments were performed to ensure the validity of the prognostic assessments made. As a result of these analyses, 47 individuals were eligible for the main analyses. The results from a stepwise regression revealed that disease progression was significantly predicted by CD4+ count at diagnosis (32% of variance) and emotional distress (17% of variance), but was unrelated to subjective perceptions of health. The data suggest that some of the variability in HIV progression can be attributed to emotional distress.

Comparison of an enzyme immunoassay (Ortho) with cell culture and immunofluorescence for the detection of genital chlamydial infection.

An enzyme immunoassay (EIA) test (Ortho Diagnostic Systems Ltd) was evaluated against cell culture for the detection of chlamydial genital infection. Specimens were obtained from 409 patients (204 men and 205 women). Sensitivity, specificity, predictive value of a positive result (PVP) and predictive value of a negative result (PVN) for the new test compared to cell culture were respectively 73.1%, 93.8%, 63.3% and 96% for men and 80%, 95.6%, 71.4% and 97.2% for women. Discrepancies were further evaluated by repeating the EIA, and by direct immunofluorescence (IF) on the EIA transport buffer. The sensitivity, specificity, PVP and PVN of the EIA against the combination of cell culture and direct IF were respectively 76.7%, 96%, 76.7% and 96% for men, and unchanged for women. Overall agreement between the EIA and the combination of cell culture and direct IF was 93.4%. The EIA is rapid and simple to perform and does not require elaborate equipment.

Comparison of ofloxacin and metronidazole for the treatment of bacterial vaginosis.

The efficacy and safety of ofloxacin, 200 mg twice daily for 7 days, was compared with metronidazole, 400 mg twice daily for 7 days, for the treatment of bacterial vaginosis (BV). Diagnosis of BV was confirmed by at least 3 of the following 4 criteria: the presence of an abnormal vaginal discharge on examination, clue cells on microscopy of vaginal specimens, vaginal pH greater than 5.0 and a positive amine test. Vaginal specimens were examined for Mobiluncus spp, analysed for the succinate/lactate (S/L) ratio and cultured for Trichomonas vaginalis, Gardnerella vaginalis, Bacteroides spp. and Mycoplasma hominis. Patients were reviewed on completion of treatment (visit 2) and 14 days later (visit 3). The diagnosis of BV was accepted in 119 of 149 patients recruited, 60 of whom received treatment with ofloxacin and 59 received metronidazole. Sixty-two patients, 31 in each treatment group, completed the study. Diagnostic cure at visit 2 was significantly better in the metronidazole group with cure rates of 56% (metronidazole) vs 23% (ofloxacin) (P = 0.001); this was associated with higher eradication rates for G. vaginalis (100% vs 56%) and Bacteroides spp. (97% vs 49%). There were no significant differences between the two groups in clinical cure at either visit 2 or 3 or in diagnostic cure at visit 3. Both treatments were well tolerated. We conclude that metronidazole is likely to remain the first choice of treatment for BV but ofloxacin offers a safe and effective alternative.

Age and sex incidence of allergic contact dermatitis.

A retrospective study of patients patch tested between 1968 and 1970 was undertaken and case records of 200 patients with unequivocal positive patch tests were studied for age and sex distribution. There was an overall female preponderance (61%), with 2 peaks of incidence in the 10-20 and 40-50 year age groups in females, but only 1 peak of incidence in the 40-50 year age group in males. There was a steady decline in all sensitivities after the 6th decade of life in both sexes. Nickel sensitivity was more common in females (92%), whereas dichromate sensitivity predominated in males (64%). Of the 200 patients, only 5(2.5%) were atopics, all of whom were females.

Efficacy of ofloxacin in the treatment of non-gonococcal urethritis in men and genital infections caused by Chlamydia trachomatis in men and women.

The efficacy of ofloxacin was evaluated in 30 men with non-gonococcal urethritis (NGU) and 17 women with Chlamydia trachomatis infection of the cervix. All were treated with ofloxacin 200 mg twice daily for seven days. Before treatment, Ch. trachomatis was isolated from 11 (37%) of the 30 men with NGU. Of these 30 men, the symptoms and signs of urethritis were eliminated in 20 (67%) two weeks after completion of ofloxacin therapy. Ch. trachomatis was not re-isolated from any of the 11 men with positive isolation before treatment. All of the group of 17 women with Ch. trachomatis infection of the cervix had complete cure two weeks after completion of ofloxacin treatment. Ofloxacin appears to be an effective treatment for lower genital tract infections with Ch. trachomatis in men and women and its efficacy in NGU appears to be comparable to standard tetracycline therapy.

HIV malingering in the accident and emergency department.

This paper reports a number of cases of patients attending an accident and emergency (A&E) department claiming to be HIV positive when they have been tested negative and are known to be negative by other departments in the hospital. The reasons for these patients claims are not always apparent. These patients may place an inappropriate workload on an already busy department. We caution doctors working in A&E departments to be vigilant when dealing with patients who claim to be HIV positive when there are no clinical or laboratory findings to substantiate the claim and we recommend liaison between relevant departments within a hospital and the patient's general practitioner (GP) when dealing with these patients.

The prevalence of skin disease in HIV infection and its relationship to the degree of immunosuppression.

A cross-sectional study of human immunodeficiency virus (HIV) positive patients who attended the HIV clinic in Brighton over a 4-month period was carried out to describe the prevalence and severity of skin manifestations in HIV-positive patients and to elucidate their association with the peripheral CD4 cell count and with the HIV disease stage. The subjects were consecutively examined by an experienced dermatologist. Skin manifestations were classified into infections, dermatoses, pruritus and neoplasm. A severity index was derived by scoring each condition as either absent, mild, moderate or severe. One hundred and fifty-one patients were enrolled with a mean age of 38.3 years. One hundred and thirty-nine were homo/bisexual men; 58 were asymptomatic and 35 had acquired immune deficiency syndrome (AIDS); 37 had CD4 counts below 200. Skin conditions were present in 138 of the 151 subjects (91.4%). The total number of events was 331. The most frequent problem was infection followed by dermatoses, pruritus and malignancy. The most frequent condition was seborrhoeic eczema followed by tinea and xerosis. We have demonstrated a statistically significant association between CD4 count, disease stage and skin manifestations in HIV-positive individuals.

Bacterial vaginosis and cervical intraepithelial neoplasia--cause or coincidence?

Evidence regarding a causal relationship between bacterial vaginosis and cervical intraepithelial neoplasia has so far been incomplete and conflicting. To determine whether bacterial vaginosis is associated with cervical intraepithelial neoplasia a retrospective study was conducted at the Genitourinary Medicine Clinic at Southlands Hospital, Shoreham-by-Sea, UK. Three hundred patients who presented to the clinic with a first diagnosis of genital warts in the absence of other sexually transmitted diseases were recruited. Results of cervical cytology and where abnormal, histology on colposcopically directed punch biopsies were collected. Bacterial vaginosis was diagnosed by the detection of clue cells on Gram-staining of a high vaginal swab, positive amine test, vaginal pH above 4.5 and the presence of characteristic vaginal discharge. Odds ratio showed an increased prevalence of cervical intraepithelial neoplasia associated with bacterial vaginosis. The results suggest that a prospective cross sectional study should be performed to formally test the hypothesis that bacterial vaginosis predisposes to cervical intraepithelial neoplasia.

Imiquimod 5% cream is an acceptable treatment option for external anogenital warts in uncircumcised males.

OBJECTIVES: To determine the safety and efficacy of imiquimod (Aldara) 5% cream in the treatment of prepuce-associated warts in uncircumcised males. METHODS: An open-label study in six UK medical centres with 35 uncircumcised males with prepuce-associated warts treated with imiquimod 5% cream three times per week for up to 16 weeks. Other anogenital warts were also treated. RESULTS: Three times weekly application of imiquimod was found to be safe, with erythema as the most commonly reported local skin reaction. Forty per cent of patients had complete clearance of anogenital warts within 16 weeks. CONCLUSIONS: Imiquimod cream at a dosing regimen of three times per week, is effective and has an acceptable safety profile in the treatment of prepuce associated warts and other external anogenital warts in uncircumcised males.