Asociación Mexicana de Hepatología A.C. Clinical guideline on hepatitis B.

Hepatitis B virus (HBV) infection continues to be a worldwide public health problem. In Mexico, at least three million adults are estimated to have acquired hepatitis B (total hepatitis B core antibody [anti-HBc]-positive), and of those, 300,000 active carriers (hepatitis B surface antigen [HBsAg]-positive) could require treatment. Because HBV is preventable through vaccination, its universal application should be emphasized. HBV infection is a major risk factor for developing hepatocellular carcinoma. Semi-annual liver ultrasound and serum alpha-fetoprotein testing favor early detection of that cancer and should be carried out in all patients with chronic HBV infection, regardless of the presence of advanced fibrosis or cirrhosis. Currently, nucleoside/nucleotide analogues that have a high barrier to resistance are the first-line therapies.

Asociación Mexicana de Hepatología A.C. Clinical guideline on hepatitis B. / Asociación Mexicana de Hepatología A.C. Guía Clínica de Hepatitis B.

Hepatitis B virus (HBV) infection continues to be a worldwide public health problem. In Mexico, at least three million adults are estimated to have acquired hepatitis B (total hepatitis B core antibody [anti-HBc]-positive), and of those, 300,000 active carriers (hepatitis B surface antigen [HBsAg]-positive) could require treatment. Because HBV is preventable through vaccination, its universal application should be emphasized. HBV infection is a major risk factor for developing hepatocellular carcinoma. Semi-annual liver ultrasound and serum alpha-fetoprotein testing favor early detection of that cancer and should be carried out in all patients with chronic HBV infection, regardless of the presence of advanced fibrosis or cirrhosis. Currently, nucleoside/nucleotide analogues that have a high barrier to resistance are the first-line therapies.

The effect of protease inhibitor-based dual antiretroviral regimens on CD4/CD8 ratio during the first year of therapy in ART-naïve patients with HIV-infection.

OBJECTIVES: To assess the effect of protease inhibitor (PI)-based dual therapy on CD4/CD8 ratio during the first year of therapy in antiretroviral therapy (ART)-naïve patients using data from randomized controlled clinical trials. METHODS: We pooled data from the GARDEL and ANDES studies, both randomized controlled clinical trials that recruited ART-naïve people living with HIV and randomly assigned them to receive PI-based dual therapy (DT) or triple therapy (TT) aiming to compare viral efficacy. We compared median CD4/CD8 ratios and the proportion of patients with CD4/CD8 ratio > 1 at 48 weeks after ART initiation in both treatment arms using the Mann-Whitney U-test and the χ2 test. We performed subgroup analysis for patients > 50 years old, with baseline CD4 counts ≤ 200 cells/µL, viral load > 100 000 HIV RNA copies/mL, and ritonavir-boosted lopinavir-based therapy. RESULTS: We analysed data from 571 patients: 292 on DT and 279 on TT. No differences were observed in CD4/CD8 ratio (0.632 vs. 0.617, P = 0.729) or in the proportion of patients with CD4/CD8 ratio > 1 (17.9% vs. 19.3%, P = 0.678) 48 weeks after ART initiation. Subgroup analysis showed no further differences. CONCLUSION: The impact of PI-based DT regimens on the CD4/CD8 ratio during the first year of treatment for ART-naïve patients is similar to that of TT.

Opsoclonus-myoclonus-ataxia syndrome associated with central nervous system HIV-1 escape phenomenon. / Síndrome opsoclono-mioclono-ataxia asociado a fenómeno de escape viral por virus de la inmunodeficiencia humana en el sistema nervioso central.

INTRODUCTION: Opsoclonus-myoclonus-ataxia (OMA) syndrome is a rare neurological disorder characterized by involuntary conjugate saccadic eye movements, myoclonus, and ataxia. Few reports exist on patients with HIV and OMA. CASE REPORT: A 41-year-old man diagnosed with HIV-1 infection in 1997 coursed with multiple anti-retroviral schemes as a consequence of poor adherence. In 2008 he presented an HIV-1 viral load of 100,000 copies/mL and a CD4+ T cell count of 10 cells/mm3. In 2013 our patient arrived with an 11-month history of progressive opsoclonus and ataxia. He had undetectable plasma HIV-1 RNA load and CD4+ of 606 cells/mm3. No opportunistic infections were found. Cerebrospinal fluid analysis showed mildly elevated protein concentration and HIV-1 viral load of 534 copies/mL. Cerebrospinal fluid co-receptor tropism test showed selective CCR5 usage. A brain magnetic resonance imaging showed hippocampal atrophy and T2-weighted hyperintensities. Our patient exhibited a dramatic recovery and cerebrospinal fluid HIV clearance after adjustment of anti-retroviral treatment based on genotyping resistance and tropism analyses. CONCLUSIONS: In patients with HIV presenting cengral nervous system dysfunction without opportunistic infections, cerebro-spinal fluid and plasma HIV-1 viral load, resistance and tropism tests should be performed to assess a potential viral escape and to design the appropriate anti-retroviral therapy in an individual patient basis.

TITLE: Síndrome opsoclono-mioclono-ataxia asociado a fenómeno de escape viral por virus de la inmunodeficiencia humana en el sistema nervioso central.Introducción. El síndrome opsoclono-mioclono-ataxia (OMA) es un trastorno neurológico infrecuente caracterizado por movimientos oculares conjugados sacádicos involuntarios, mioclonías y ataxia. Existen pocos casos en la bibliografía de pacientes con virus de la inmunodeficiencia humana (VIH) y OMA. Caso clínico. Varón de 41 años y diagnóstico de infección por el VIH-1 desde 1997, que cursó con múltiples esquemas antirretrovirales debido a una pobre adhesión al tratamiento. En 2008 presentó una carga viral de 100.000 copias/mL y una cuenta linfocitaria CD4+ de 10 células/mm3. En 2013 sufrió un cuadro progresivo de 11 meses de evolución caracterizado por opsoclonía y ataxia. En ese momento, su carga viral era indetectable, y la cuenta de CD4+, de 606 células/mm3. Se descartaron infecciones oportunistas. El examen del líquido cefalorraquídeo demostró hiperproteinorraquia leve y una carga viral de 534 copias/mL. El examen del tropismo de correceptor en el líquido cefalorraquídeo demostró un uso selectivo de CCR5. La resonancia magnética cerebral objetivó atrofia hipocámpica e hiperintensidades en las secuencias ponderadas en T2. El paciente mostró una recuperación clínica franca y un aclaramiento de la carga viral en el líquido cefalorraquídeo tras el ajuste de antirretrovirales basado en la resistencia de genotipo y el análisis de tropismo. Conclusiones. En pacientes con infección por el VIH y disfunción del sistema nervioso central sin infecciones oportunistas, debería llevarse a cabo una determinación de la carga viral en el plasma y el líquido cefalorraquídeo para descartar un potencial fenómeno de escape viral, así como exámenes de resistencia y tropismo para diseñar el tratamiento antirretroviral adecuado.

Myocardial Inflammatory Changes Before and After Antiretroviral Therapy Initiation in People With Advanced Human Immunodeficiency Virus Disease.

Because of the high frequency of late presentation of human immunodeficiency virus (HIV) disease in our population, we decided to explore the presence of myocarditis among people with HIV infection and advanced immunosuppression (less than 200 CD4+ cells/µL) and to describe the inflammatory changes observed after combined antiretroviral therapy initiation in an observational, longitudinal, prospective cohort. We performed both cardiovascular magnetic resonance imaging and doppler transthoracic echocardiogram.

Immediate treatment of acute HIV in a tertiary healthcare center: bridging gaps in communication using smartphones.

OBJECTIVES: Early initiation of antiretroviral therapy (ART) during acute HIV infection is associated with favourable clinical and epidemiological outcomes. Barriers to prompt treatment initiation limit the benefits of universal access to ART in Mexico. We sought to create an algorithm for the immediate detection and treatment of patients with acute HIV infection. METHODS: A nationwide cohort of patients with acute HIV infection was created in 2015. In order to identify cases and treat them promptly at our centre, an interdisciplinary group coordinated through an instant-messaging tool using smart phones was established. When a probable case was detected, a discussion was initiated to confirm the diagnosis and facilitate the administrative processes to initiate ART as soon as possible. We compared time to ART initiation with that in a comparison group of patients with chronic HIV infection enrolled during the same period (May 2015 to February 2017) through routine care, using survival analysis estimators and log-rank tests. RESULTS: We recruited 29 patients with acute HIV infection. The median time to ART initiation was 2 days in these patients, in contrast to 21 days for patients with chronic infection. There were no significant differences in the percentages of patients engaged in care, on treatment or virologically suppressed at 1 year of follow-up. CONCLUSIONS: Implementing immediate ART initiation programmes is feasible in Mexico, in spite of the substantial administrative barriers that exist in the country. More extensive replication of this model in other centres and in patients with chronic infection is warranted to evaluate its effect on the continuum of care.

Trends in proportion of older HIV-infected people in care in Latin America and the Caribbean: a growing challenge.

We aimed to quantify the proportion of people receiving care for HIV-infection that are 50 years or older (older HIV patients) in Latin America and the Caribbean between 2000 and 2015 and to estimate the contribution to the growth of this population of people enrolled before (<50yo) and after 50 years old (yo) (⩾50yo). We used a series of repeated, cross-sectional measurements over time in the Caribbean, Central and South American network (CCASAnet) cohort. We estimated the percentage of patients retained in care each year that were older HIV patients. For every calendar year, we divided patients into two groups: those who enrolled before age 50 and after age 50. We used logistic regression models to estimate the change in the proportion of older HIV patients between 2000 and 2015. The percentage of CCASAnet HIV patients over 50 years had a threefold increase (8% to 24%) between 2000 and 2015. Most of the growth of this population can be explained by the increasing proportion of people that enrolled before 50 years and aged in care. These changes will impact needs of care for people living with HIV, due to multiple comorbidities and high risk of disability associated with aging.

Functional Outcomes 18 Months After Total and Midarm Transplantation: A Case Report.

BACKGROUND: The function reported after arm transplantation is deemed beneficial relative to the marked disability that upper arm amputation causes. OBJECTIVE: We report a 51-year-old man with a Disabilities of the Arm, Shoulder and Hand (DASH) score of 75.83 who underwent bilateral arm transplantation in October 2015. PROCEDURE: The right arm was transplanted at the glenohumeral joint level, including transplantation of the humeral head, joint capsule, and rotator cuff ligaments and tendons. Additionally, neurorrhaphies were performed at the origin of the terminal branches of the brachial plexus, including the axillary and musculocutaneous nerves. Therefore, this was considered a total arm transplantation. The left arm was transplanted at the transhumeral level, with complete transplantation of the biceps and triceps brachii, and terminolateral neurorrhaphy of the donor musculocutaneous nerve to the receptor radial nerve. A maintenance triple immunosuppression scheme was administered, with tacrolimus levels kept at 10 ng/mL. RESULTS: At 18 months post-transplantation, the intrinsic musculature in the left hand showed electrical registry, DASH score was 67.5, Carroll test score was 28 in both extremities, Hand Transplant Score System was 67.5 in the right extremity and 77.5 in the left extremity, and Short Form-36 score was 96.1. The patient was healthy, with restored body integrity. He could lift medium-sized weightless objects, eat and go to the bathroom by himself, drink liquids with bimanual grasp, swim, dress almost independently, and drive. CONCLUSION: The functional evolution of the patient was similar to previously reported transplanted arms, even though the right arm transplant involved the glenohumeral joint and axillary and musculocutaneous nerve repair.

Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial.

PURPOSE: We investigated the effects of maraviroc, the first approved CC-chemokine receptor 5 (CCR5) antagonist, on blood lipids in a post hoc analysis of the phase 3 MERIT study in treatment-naïve patients. METHODS: Patients received maraviroc 300 mg twice daily (n = 360) or efavirenz 600 mg once daily (n = 361), both in combination with zidovudine/lamivudine, for up to 96 weeks. Baseline and on- treatment lipid profiles were analyzed according to National Cholesterol Education Program (NCEP) thresholds. RESULTS: Baseline characteristics and lipid profiles were comparable between groups. Among patients with total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c) below NCEP treatment thresholds at baseline, significantly more efavirenz- than maraviroc-treated patients exceeded those thresholds at 96 weeks (TC: 35% [74/209] vs 11% [20/188], P < .0001; LDL-c: 23% [47/197] vs 8% [15/183], P < .0001). Among patients exceeding NCEP thresholds at baseline, significantly more efavirenz- than maraviroc-treated patients exceeded the thresholds at 96 weeks (TC: 83% [24/29] vs 50% [17/34], P = .0084; LDL-c: 86% [19/22] vs 55% [16/29], P = .0314). Of those with baseline high- density lipoprotein cholesterol (HDL-c) < 40 mg/dL, 43% (56/130) of maravirocand 62% (86/139) of efavirenz-treated patients achieved HDL-c≥40 mg/dL at 96 weeks (P = .0020). CONCLUSIONS: Maraviroc was not associated with elevations in TC, LDL-c, or triglycerides and showed beneficial effects on lipid profiles of dyslipidemic patients.

Laparoscopic approach to fever of unknown origin.

BACKGROUND: Fever of unknown origin (FUO) is difficult to diagnose. Laparotomy is needed to establish the etiologic diagnosis in some patients. The aim of this study was to analyze the feasibility, safety, and success rate of a protocolized laparoscopy in patients with FUO. METHODS: An extensive clinical evaluation was performed before surgery. Laparoscopy included inspection of the abdominal cavity, wedge and tru-cut liver biopsies, lymph node biopsy, splenectomy, and bone marrow biopsy. Histologic analysis, permanent section analysis, and cultures were obtained. RESULTS: The study involved 15 patients with a mean age of 43.6 +/- 14.5 years. The mean operative time was 122 +/- 60 min. Minor complications occurred in 9% of the patients. One patient bled after surgery and underwent reoperation. There was no operative mortality. An etiologic diagnosis was made in 66% of the patients, and laparoscopy helped to rule out intraabdominal pathology in four additional patients, giving a total success rate of 93%. CONCLUSION: Protocolized laparoscopy in patients with FUO is safe, feasible, and accurate.

High prevalence of oncogenic human papillomavirus in the genital tract of women with human immunodeficiency virus.

OBJECTIVE: The goal of this study was to determine the prevalence of human papillomavirus (HPV) and squamous intraepithelial lesions (SILs) in women infected with human immunodeficiency virus (HIV) in Mexico. METHODS: Cases included women who were positive for human immunodeficiency virus (HIV) and accepted to participate. There were two control groups in this study: group A, heterosexual partners of HIV+ men; group B, commercial sex workers. Gynecologic examination was performed in all participants. Also, a cervical smear with colposcopy and a sample for detection of HPV DNA by polymerase chain reaction (PCR) were obtained in all subjects, as were CD4+ counts. Relative risks (RR) and 95% confidence interval were calculated. RESULTS: Eighty-five HIV+ women agreed to participate in this study; the route of HIV infection was heterosexual in 78.8%; transfusion in 8.2%; paid donors in 3.5%; and 9.4% unknown. A total of 9 controls were included: 4 from group A and 5 from group B. HPV DNA was detected by PCR in 57 (69%) cases and in 26 (29%) controls from both groups (P < 0.0001). The RR of HPV infection was 5.5 (2.7-11.5). Also, a significant difference in the prevalence of high-risk HPV types was observed between cases and controls, RR = 12.8 (4.07-42.9). These associations were independent of CD4+ counts and antiretroviral therapy. No association was observed between HIV infection and the risk for high-grade SIL. CONCLUSIONS: We observed a high prevalence of oncogenic HPV types in HIV-positive women. These women should be screened regularly for early diagnosis of premalignant lesions and prevention of cervical cancer.

Toxic pseudomembranous colitis in a patient with ulcerative colitis.

UNLABELLED: Toxic colitis is a severe disease that may be caused by several inflammatory and/or infectious diseases. Ulcerative colitis is one of the most frequent causes of toxic colitis in the United States. Toxic megacolon complicating Clostridium difficile colitis is a rare occurrence with significant morbidity and mortality. CASE REPORT: A 52-year-old male presented with rectal bleeding and tenesmus. He had been treated for amebiasis with metronidazole, and had improved. Two weeks later, symptoms recurred, and he was referred to our hospital. A sigmoidoscopy and biopsies demonstrated mucosal ulcerative colitis. He underwent treatment with systemic prednisone, mesalamine, and hydrocortisone enemas with adequate response. He was asymptomatic for 2 months, but later presented with a tender abdomen and rectal bleeding. Plain abdominal and thorax films showed colonic distention and free intraperitoneal air. Emergency laparotomy was performed, and an inflamed and distended colon, with free inflammatory liquid in the peritoneum, was found. A total abdominal colectomy with temporary ileostomy and Hartmann's pouch was performed. The histopathology analysis demonstrated a Clostridium difficile pseudomembranous colitis. CONCLUSION: The presence of toxic megacolon due to Clostridium difficile in patients with ulcerative colitis is a rare complication that may be suspected in patients with initial relapse who are on antibiotics.

[Significance of intracranial hypertension management in cryptococcal meningitis in patients with acquired immunodeficiency syndrome. Report of 2 cases]. / Importancia del manejo de la hipertensión endocraneana en meningitis criptocócica en pacientes con síndrome de inmunodeficiencia adquirida. Informe de dos casos.

Two cases of cryptococcal meningitis and increased intracranial pressure in patients with acquired immunodeficiency are described. Both patients presented high intracranial pressure that persisted despite optimal antifungal treatment (amphotericin B, 5-flucytosine initially, and fluconazole posteriorly). The elevated intracranial pressure produced headache, seizures, and reduced visual and auditory acuity. CAT scan demonstrated absence of ventricular dilatation or focal lesions. Both cases were treated with adequate antifungal therapy, as well as with repeated lumbar punctures and placement of a lumboperitoneal shunt due to the persistence of elevated intracranial pressure. One patient presented with unilateral loss of vision due to optic nerve atrophy. After one year of follow-up, one patient died due to progression of his disease, while the other is still alive and without evidence of neurological disease. Intracranial hypertension is a frequent clinical manifestation of cryptococcal meningitis in patients with acquired immunodeficiency syndrome (AIDS) that requires adequate diagnosis and management. Treatment should be directed towards the reduction of intracranial pressure though repeated lumbar punctures and, in some cases, with lumboperitoneal or ventricular-peritoneal shunts.

[Coccidioides immitis: primary infection of the central nervous system. Case report and literature review]. / Coccidioides immitis: infección primaria del sistema nervioso central. Informe de un caso y revisión de la literatura.

A case of primary coccidiodal meningitis without pulmonary, osseous or dermic affection due to Coccidioides immitis in a 27 years old male patient with hypertensive brain of one month of evolution, was reported. The patient was resident of Northern California, and he was previously healthy. The cerebrospinal fluid (CSF) showed a glucose of 22 mg/dL, proteins 62 mg/dL, white blood cells 100/mm3 (97% PMN, 3% MN). CT SCAN showed bilateral ventricular dilatation. Diagnosis of coccidioidal meningitis was made based on antibodies against anticoccidioides (IgM 6.8 mg/dL and IgG 4.9 mg/dL, normal < 2 mg/dL) and growth of Coccidioides immitis. The chest radiograph was normal and the detection of antibodies against human immunodeficiency virus was negative. A VP shunt was placed and the patient was treated with intravenous amphotericin B and intratecal amphotericin B through on Ommaya reservoir. Even with antifungal treatment the patient deteriorated neurologically after an initial transient improvement, he died two weeks later in his hometown.

Thalidomide as therapy for human immunodeficiency virus-related oral ulcers: a double-blind placebo-controlled clinical trial.

A double-blind, randomized, placebo-controlled clinical trial was performed in Mexico City to evaluate the efficacy of thalidomide in treating oral recurrent aphthae in human immunodeficiency virus (HIV)-infected subjects. Sixteen HIV-infected patients with clinical and histological diagnosis of oral recurrent aphthous ulcerations received randomly an 8-week course of either thalidomide or placebo, with an initial oral dosage of 400 mg/d for 1 week, followed by 200 mg/d for 7 weeks. Ten subjects received thalidomide and six received placebo. At 8 weeks, nine subjects (90%) in the thalidomide group had complete healing of their ulcers, compared with two (33.3%) of the six patients in the placebo group (P = .03). There was a significant reduction in largest ulcer diameter in the thalidomide group. Rash was observed in 80% of the thalidomide patients. Although thalidomide demonstrated an unquestionable benefit in treatment of oral ulcers in HIV patients, caution must be taken given the frequent occurrence of side effects.

Oral manifestations of HIV infection by gender and transmission category in Mexico City.

A cross-sectional analysis was conducted in Mexico City from September 1989 to March 1996, to determine the prevalence of HIV-related oral manifestations by gender and route of HIV transmission. The diagnosis of HIV-associated oral lesions was based on preestablished criteria. For the statistical analysis chi-squared and Fisher's exact tests were used where appropriate. Odds ratios were calculated as estimates of the relative risks. Control of confounding factors was performed by logistic regression models. Oral lesions were present in 75% of 436 HIV+ patients. Hairy leukoplakia, erythematous and pseudomembranous candidosis, angular cheilitis and oral ulcers were frequently found. Patients who contracted HIV through blood transfusion were more likely to present erythematous candidosis (P=0.005) than subjects who acquired HIV through sexual transmission. Oral ulcers were seen only in men (P=0.02) and in individuals who contracted HIV through sexual transmission (P=0.02). This study brings valuable data in regard to differences in the type and prevalence of HIV-related oral lesions by gender and the risk categories analysed, particularly blood transfusion.

PIP: A cross-sectional analysis conducted in Mexico City, Mexico, in 1989-96 investigated the prevalence of HIV-related oral manifestations by gender and route of HIV transmission. The 436 HIV-positive patients enrolled in this study were part of a larger, ongoing study conducted through the Infectious Diseases Clinic in Mexico City. The primary mode of HIV transmission was blood transfusion among female respondents (63%) and sexual activity among male respondents (90%). 71% of subjects had at least 1 (mean, 1.3) HIV-related oral lesion, including hairy leukoplakia, erythematous and pseudomembranous candidosis, angular cheilitis, and oral ulcers. Candidosis, pseudomembranous candidosis, hairy leukoplakia, exfoliative cheilitis, and xerostomia were all significantly associated with a CD4 count under 200 cells/cu. mm and were more prevalent among those with advanced HIV disease. Oral ulcers were present only in men. Women had a higher prevalence than men of hyperpigmentation (10.5% vs. 4%) and xerostomia (7% vs. 2%), but these differences were not significant. Multivariate analysis revealed a significant association between erythematous candidosis and blood transfusion, even after controlling for gender, clinical stage, CD4 count, antiretroviral therapy, smoking history, and xerostomia.

Fulminant amebic colitis: analysis of 55 cases.

UNLABELLED: Fulminant amebic colitis is a rare disease with high morbidity and mortality. PURPOSE: This study was designed to identify the most frequent clinical and histopathologic features of fulminant amebic colitis and to analyze results of surgical treatment and the existence of risk factors for mortality. MATERIALS AND METHODS: A retrospective analysis was conducted of clinical and histopathologic data of 55 patients with fulminant amebic colitis. Data were obtained from the files of autopsies and surgical operations that had been performed at a referral center in Mexico from 1943 through 1994. RESULTS: Median age was 52 (range, 18-79) years. There were 34 men (62 percent) and 21 women (38 percent). Diabetes mellitus and chronic alcoholism were the most frequent diseases in association with fulminant amebic colitis (40 and 31 percent, respectively). The most frequent clinical manifestations were abdominal pain, diarrhea, rectal bleeding, and fever. There was a coexistent amebic liver abscess in 54 percent of patients. The main histopathologic characteristics were necrosis, presence of trophozoites, and acute and/or chronic inflammation. Of 25 patients who underwent surgery, only six survived (operative mortality, 76 percent; overall mortality, 89 percent). The variables that correlated with mortality were longer duration of symptoms, lower count of leukocytes, nonsurgical treatment, nonresective surgical procedure, hospital admission before 1971, and invasion of trophozoites into or through the muscularis. CONCLUSIONS: The results may help to obtain an earlier diagnosis and establish proper treatment of fulminant amebic colitis.

Safety and efficacy of Virend for topical treatment of genital and anal herpes simplex lesions in patients with AIDS.

Virend (SP-303), a new topical antiviral agent with activity against herpesvirus, was evaluated in a multicenter, double-blind, placebo-controlled Phase II study for safety and effectiveness against recurrent genital herpes lesions in patients with AIDS. The primary endpoints of this study were complete healing of lesions and time to healing. Patients had a history of recurrent genital or anogenital herpes with at least one lesion and positive HSV culture at enrollment. Participants received Virend (15% ointment; 24 patients) or matching placebo (21 patients) three times a day for 21 days. Excluding two patients in the Virend group who received an initial treatment but were lost to follow-up, 9 of 22 (41%) patients treated with Virend experienced complete healing of their lesions compared with three (14%) patients in the placebo group (P = 0.053). Viral culture revealed that 50% of Virend-treated patients and 19% of placebo-treated patients became culture-negative during treatment (P = 0.06). Based on these preliminary clinical findings, further evaluation of Virend for topical treatment of genital herpes in patients with AIDS is planned.