Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis.

Sertaconazole is a new antifungal agent. To compare the efficacy and tolerability of sertaconazole and miconazole cream in cutaneous dermatophytosis, this prospective, randomized, multicentric comparative, phase 4 study was undertaken in 260 patients with cutaneous dermatophytosis after approvals from Institutional Ethics Committees. Patients were assigned to sertaconazole cream (2%) or miconazole cream (2%) topically twice daily for 2 weeks after obtaining informed consent. Efficacy variables included changes in mean scores of erythema, pruritus, desquamation, erythema/itching, burning/weeping, scaling/pustule and overall global assessment. Safety and tolerability were also assessed. A total of 122 patients in the sertaconazole group and 128 in the miconazole group completed the study with 10 drop-outs. There was a significant decrease (P < 0.05) in mean symptom scores and total scores from the first week onwards, sustained till 2 weeks and statistically significant (P < 0.05) in favour of sertaconazole. Moreover, 62.3% patients had complete clinical cure in the sertaconazole group (P < 0.05) compared with 44.6% in miconazole users. Both drugs were well tolerated and five patients in the sertaconazole group and nine in the miconazole group reported mild to moderate adverse events. Therapy with sertaconazole cream (2%) provided a better efficacy and tolerability compared with the miconazole cream (2%) and could thus be a therapeutic option in cutaneous dermatophytosis.

Physician estimate of antiretroviral adherence in India: poor correlation with patient self-report and viral load.

Adherence to antiretroviral therapy (ART) is critical in maintaining viral suppression and minimizing resistance in HIV-infected patients. We compared physician estimates of their patients' ART adherence with participant's self-reported adherence to determine patient-provider agreement and identify correlates of discordance in three private clinics in Mumbai, India. Between December 2004 and April 2005, 277 persons receiving ART at three private clinics in Mumbai, India, were interviewed regarding adherence to ART using the Adult AIDS Clinical Trials Group questionnaire. Physicians were also asked to assess their patients' adherence. Quantitative HIV-1 RNA level was determined for 200 participants. Agreement between provider estimate of adherence and participant self-report was low, kappa = 0.058 (95% confidence interval [CI] 0.011-0126). Of 200 participants whose viral load was obtained, viral suppression was associated with participant self-reported adherence (odds ratio [OR] 3.08; 95% CI 1.65-5.74; p < 0.05), but not with provider estimated adherence (OR 1.2; 95% CI 0.67-2.14; p = 0.54). Cost of ART was positively associated with physician underestimation of participant adherence and older age was negatively associated. No independent correlates of physician overestimation of participant adherence were found. There was poor agreement between physician estimate of adherence and patient self-report. Providers should avoid using their own assessment of patient ART adherence. Instead, providers should rely on effective and validated measures, especially when viral load or drug level monitoring are not readily available.

Aloe vera: a short review.

Aloe vera is a natural product that is now a day frequently used in the field of cosmetology. Though there are various indications for its use, controlled trials are needed to determine its real efficacy. The aloe vera plant, its properties, mechanism of action and clinical uses are briefly reviewed in this article.

Improving adherence to antiretroviral therapy.

Antiretroviral therapy (ART) has transformed HIV infection into a treatable, chronic condition. However, the need to continue treatment for decades rather than years, calls for a long-term perspective of ART. Adherence to the regimen is essential for successful treatment and sustained viral control. Studies have indicated that at least 95% adherence to ART regimens is optimal. It has been demonstrated that a 10% higher level of adherence results in a 21% reduction in disease progression. The various factors affecting success of ART are social aspects like motivation to begin therapy, ability to adhere to therapy, lifestyle pattern, financial support, family support, pros and cons of starting therapy and pharmacological aspects like tolerability of the regimen, availability of the drugs. Also, the regimen's pill burden, dosing frequency, food requirements, convenience, toxicity and drug interaction profile compared with other regimens are to be considered before starting ART. The lack of trust between clinician and patient, active drug and alcohol use, active mental illness (e.g. depression), lack of patient education and inability of patients to identify their medications, lack of reliable access to primary medical care or medication are considered to be predictors of inadequate adherence. Interventions at various levels, viz. patient level, medication level, healthcare level and community level, boost adherence and overall outcome of ART.

An open study to evaluate the efficacy and safety of tazarotene gel (0.1%) in acne vulgaris.

BACKGROUND: Tazarotene is a new third generation topical acetylenic retinoid. The present study was conducted to evaluate the efficacy and safety of tazarotene gel (0.1%) in Indian patients of acne vulgaris. METHODS: The present study was a prospective, open, multicentric, phase III trial. The duration of study was 14 weeks, including a 12-week active treatment period, preceded by a 2-week washout phase. Patients applied 0.1% tazarotene gel as a thin film over the affected area once daily in the evening. The efficacy was evaluated by analyzing changes in the number of facial acne lesions and patient's and physicians' global assessment. The efficacy parameters were assessed at baseline, visits 2, 4, 8, and 12 weeks. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. RESULTS: A total of 126 patients in 6 centers completed the study. At the end of the 8th and 12th weeks, the mean number of inflammatory lesions reduced by 70.6% and 86.1%, non-inflammatory lesions by 81.5% and 92%, and total lesion count 75.6% and 88.8% respectively from baseline. Also, 90.7% and 93.6% of total study cases showed complete to moderate clearance of acne lesions according to physicians at the end of the 8th and 12th weeks. CONCLUSIONS: This study confirms the efficacy and safety of tazarotene gel (0.1%) in Indian patients of acne vulgaris.

Evaluation of the efficacy, safety and tolerability of Tacrolimus ointment in Indian patients of moderate to severe atopic dermatitis: a multicentric, open label, phase III study.

AIM OF STUDY: Tacrolimus, a topical immunomodulator, has been introduced as a new treatment for moderate to severe atopic dermatitis. The present study was conducted to evaluate the efficacy, safety and tolerability of Tacrolimus ointment in patients of atopic dermatitis in an Indian setting. METHODS: The present study was a prospective, open, multicentric, Phase III trial. The duration of study was 5 weeks, including a 3-week active treatment period, preceded by a 1-week washout phase and followed by a 1-week follow-up phase. Patients diagnosed to be suffering from moderate to severe atopic dermatitis as per the Rajka and Langeland criteria were treated with Tacrolimus ointment 0.03% twice daily. Efficacy was assessed by modified Eczema Area Sensitivity Index (mEASI) score, patient's and physician's global assessment. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. RESULTS: There was a statistically significant decrease in the modified Eczema Area Sensitivity Index (mEASI) score (P< 0.05). Patient's and Physician's global evaluation of treatment was complete resolution to very good improvement in most of the patients. The laboratory values were within normal limits. The drug was well tolerated. CONCLUSIONS: This study confirms the efficacy and safety of Tacrolimus ointment 0.03% in Indian patients of moderate to severe atopic dermatitis.

Efficacy and safety of butenafine in superficial dermatophytoses (tinea pedis, tinea cruris, tinea corporis).

Superficial dermatophytoses of skin are very common infections seen in clinical practice. Besides topical imidazoles, triazoles and allylamines, topical butenafine (a benzylamine derivative) is a novel agent with broad antifungal activity. One hundred and eleven patients with tinea infections were enrolled in this multicentric, randomised, single-blind non-comparative study, which involved application of butenafine (1%) cream in tinea pedis (4 weeks) and tinea cruris and tinea corporis (2 weeks) cases. The results showed that butenafine causes rapid resolution of signs and symptoms (erythema itching, burning, crusting, scaling, etc), with good patient and physician acceptability of treatment. The broader spectrum fungicidal activity and better drug retention in superficial skin layers may be responsible for this beneficial effect.

Increased promoter diversity reveals a complex phylogeny of human immunodeficiency virus type 1 subtype C in India.

OBJECTIVE: To evaluate human immunodeficiency virus type 1 (HIV-1) long terminal repeat (LTR) sequence diversity among distinct populations within India and to determine the prevalent subtype. STUDY DESIGN/METHODS: Analysis of the 3'LTR was conducted from 28 HIV-1-positive samples: 1992-1993 (Pune, New Delhi) and 1995-1996 (Pune, Mumbai and Vellore). Genomic DNA was extracted from cocultivated peripheral blood mononuclear cells (PBMCs) and used for polymerase chain reaction (PCR) amplification and sequencing using dye terminator chemistry. Sequences were edited, aligned, and analyzed phylogenetically utilizing gap-stripped and bootstrapping parameters. Mobility shift assays were used to confirm binding activity. RESULTS: All nucleotide sequences were HWV-1 subtype C based on phylogenetic analysis. The isolates from Pune/Delhi formed subclusters when analyzed separately, irrespective of time or sample source. However, no significant subclustering was observed with isolates from Mumbai or Vellore or with the entire sample set when analyzed collectively. Subtype-specific enhancer analysis revealed an expected third NF-kappaB site but also revealed six isolates with insertions and deletions not previously described, one of which resembles an AP-1 binding site. CONCLUSIONS: The results confirm the prevalence of HIV-1C and suggest increasingly complex phylogeny of HIV-1C within India, such that the previously observed subclustering may no longer adequately reflect the diversity of isolates currently circulating throughout India.

Seronegative HIV-2 carriers in India.

The discordant cases of seronegative, but culture and proviral HIV-2 DNA positive were found in Mumbai, India. This was corroborated by the successful isolation of HIV-2-RNA in culture medium, HIV-2 cDNA sequence determination and the detection of the antigen. The sequence of the isolated HIV-2 genomic RNA does not seem to be altered to the extent that the change will alter antibody binding. Furthermore, antibody from the same individual (even at 8 months from initial sampling) from whom HIV-2 was isolated did not react with the antigen of this strain. Those evidences imply that extremely low or non-production of the antibody may be due to suboptimal immune stimulation due to extremely slow HIV-2 replication. This low virus-load may be responsible for the negative antibody results in the HIV-2 carriers.

PIP: This paper describes the characteristics of HIV-2 seropositive and seronegative cases in Mumbai, India, and characterizes the differences between HIV-1 and HIV-2. More than 200 outpatients considered to be at high risk of HIV infection were screened for HIV-1 and HIV-2 antibody and proviral DNA. The study found 11 cases that were discordant for antibody test and HIV proviral DNA (i.e., negative for anti-HIV but positive for HIV-2 proviral DNA). The presence of this provirus was further corroborated by the detection of HIV-2 RNA in the culture medium upon HIV isolation, HIV-2 cDNA sequencing, and antigen detection. The sequence of the isolated HIV-2 genomic RNA did not seem to be altered to the extent that the change would affect antibody binding. Moreover, antibody from the same person in whom HIV-2 was detected did not react with the antigen of this strain even 8 months after the initial sampling. These findings indicate that extremely low production or non-production of the antibody may be brought about by suboptimal immune stimulation due to very low HIV-2 replication speed. This low virus load may account for the negative antibody results in the HIV-2 carriers in India.

Cyclospora infection in acquired immunodeficiency syndrome.

BACKGROUND: Diarrhea is a common clinical manifestation of human immunodeficiency virus (HIV) infection. The important protozoan pathogens causing diarrhea include cryptosporidium, microsporidium, Isospora belli and cyclospora besides giardia lamblia and entamoeba histolytica. OBJECTIVE: The objective of the present study was to determine the incidence of cyclospora (a coccidian protozoan) infection in HIV infected patients. METHODOLOGY: Faecal smears were stained by modified acid fast staining method to demonstrate oocysts of cyclospora. RESULTS: Out of 334 faecal specimens which were studied, cyclospora were identified in 22 cases (6.6 percent); and in 50 percent of the patients, there was a mixed infection with another protozoan parasite namely cryptosporidium. CONCLUSION: Identification of this parasite is important because cyclosporiasis can be treated with trimethoprim-sulfamethoxazole. Outbreaks of cyclospora infection have been linked to waterborne transmission. Though adequately chlorinated water is free of coliforms, it can still contain cyclospora.

Evaluation of safety and efficacy of ketoconazole 2% and zinc pyrithione 1% shampoo in patients with moderate to severe dandruff--a postmarketing study.

A postmarketing study was conducted on 236 patients from 23 centres suffering from moderate to severe dandruff with a combination of ketoconazole and zinc pyrithione (1%) for a duration of 4 weeks with 2 weeks further follow-up. Scoring of dandruff was done on a 0-10 scale for each of the 6 regions of scalp at each week up to 6 weeks. The results indicate that there was a consistent improvement in dandruff scores over the treatment period and a reduction of > 90% was seen for all areas of scalp individually as well as collectively as compared to baseline. The treatment also showed significant improvement in other signs and symptoms such as erythema and itching, with a highly favourable adverse event profile. The overall assessment for global improvement by investigators showed good-excellent results with high acceptability amongst the patient population for the treatment. A combination shampoo of ketoconazole (2%) and zinc pyrithione (1%) offers a safe and effective option in the treatment of dandruff.