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PubMedDate not supplied

Preliminary experiences with ritonavir in children with advanced HIV infection.

The aim of this study was to obtain information on the feasibility (tolerance, safety) of antiretroviral combination therapy, including ritonavir, in children. In eight children (median age 8.9 years; range 3 to 13 years) with advanced HIV disease (median CD4+ lymphocyte count at baseline, 80 cells/microliter; range 0 to 280 cells/ microliter), drug combinations including ritonavir (approximately 300 mg/m2 b.i.d.) were administered. In seven children, previous therapy using a combination of at least two nucleoside reverse transcriptase inhibitors (NRTI) had failed. Four patients had ritonavir added to an already existing regimen of two NRTI; two patients had one NRTI replaced by a new one; and in two patients two new NRTI were initiated. The number of CD4 T cells, plasma HIV RNA concentration, CBC and blood chemistry profile were monitored. Medication had to be discontinued in two children because of severe nausea and vomiting. In the remaining six children, ritonavir was tolerated and treatment was maintained for at least 6 months. The number of CD4 cells increased in five of six patients. The median number of CD4 cells increased from 66 +/- 110 cells/microliter at baseline to 92 +/- 99 cells/microliter, 161 +/- 88 cells/microliter, and 252 +/- 25 cells/microliter after 1, 3 and 6 months of therapy, respectively. The plasma HIV RNA concentration decreased below the detection limit of 500 copies/ml in three children. In the remaining children a maximum reduction of 0.8, 1.0 and 1.8 log10 was observed. In one child the HIV RNA concentration reincreased after 6 months by 0.7 log10 above the nadir. Antiretroviral combinations including ritonavir were tolerated by six of eight children and produced substantial benefits with respect to increased numbers of CD4 cells and a decline in plasma viral RNA concentration. It can be concluded that the administration of ritonavir is possible in a significant proportion of HIV-infected children, and leads to improvement of the CD4 cell count and viral load.

Adolescent↗
PubMed1994

Cervicovaginal screening in women with HIV infection: a need for increased vigilance?

OBJECTIVE: To review the current literature on cervical disease (dysplasia, cervical intraepithelial neoplasia [CIN] or carcinoma) in women with HIV infection and to assess recommendations for cervicovaginal screening in these patients. DATA SOURCES: MEDLINE and AIDSLINE were searched for relevant articles published in English or French between January 1987 and February 1993, abstracts presented at international AIDS conferences from 1989 to 1993 were evaluated, and pertinent agencies and organizations were consulted. STUDY SELECTION: A total of 92 reports of gynecologic disease in women with HIV infection were examined; 32 studies were retained that reported pertinent findings on cervical dysplasia, CIN or cervical carcinoma. DATA EXTRACTION: The following criteria were used to extract data: study design (descriptive v. comparative), sample size, heterogeneity of the study population, presence of immunodeficiency indicators (i.e., absolute CD4+ lymphocyte count) and presence of concomitant vaginal infections. Recommendations were assessed for their specific application to women with HIV infection. DATA SYNTHESIS: Data on the associations between stage of cervical disease and response to treatment at varying levels of CD4+ lymphocyte depletion were incomplete. Recommendations by official bodies for cervicovaginal screening in women with HIV infection differed little from recommendations for standard care of all women of reproductive age. CONCLUSIONS: The consequences of a missed or delayed diagnosis of cervical disease for women with HIV infection can be severe. Pending further research, more frequent cervicovaginal screening through Papanicolaou testing and colposcopy in women with HIV infection is warranted.

Adult↗
PubMed1991

Decreased serum dehydroepiandrosterone is associated with an increased progression of human immunodeficiency virus infection in men with CD4 cell counts of 200-499.

Dehydroepiandrosterone (DHEA) and its interconvertible sulfate derivative (DHEA-S) are human androgenic steroids that have been reported to inhibit viral expression and have been associated with a decreased risk of cancer. The relationship between serum DHEA and DHEA-S levels and subsequent progression to AIDS was investigated in a sample of human immunodeficiency virus (HIV)-infected men from the San Francisco Men's Health Study followed prospectively since 1984. Among 108 men seropositive for HIV at study entry and with CD4 lymphocyte counts of 200-499 microliters 24 months later, serum DHEA levels below the lower limit of normal (less than 180 ng/dl) at this later date were predictive of subsequent progression to AIDS (relative hazard = 2.34; 95% confidence interval = 1.18-4.63; P = .01) after controlling for hematocrit, age, and log absolute CD4 cell number in a Cox proportional hazards model. This is the first large prospective cohort in which an endocrinologic variable has been observed to independently predict progression to AIDS. These observations, in addition to recent in vitro data, suggest that DHEA might have a protective effect in HIV infection.

Adult↗
PubMed1991

Frequency and prognostic importance of thrombocytopenia in symptom-free HIV-infected individuals: a 5-year prospective study.

The exact frequency of HIV-associated thrombocytopenia (TCP), defined as platelet count less than 150 x 10(9)/1, was studied in 435 symptom-free HIV-seropositive individuals. At the baseline control, 23 (5.5%) had TCP. TCP individuals had a significantly lower mean CD4 lymphocyte count than the non-TCP individuals. During a mean follow-up of 30 months, 79 out of the 435 individuals (18%) had TCP at least once. During the study period, only 1% of our patients had a platelet count less than 50 x 10(9)/l. TCP was more frequent in intravenous drug users than in other risk groups. A spontaneous normalization of platelet count was observed in more than 50% of TCP individuals.

Adult↗
PubMed1991

Phase 1 study of recombinant human CD4-immunoglobulin G therapy of patients with AIDS and AIDS-related complex.

The safety and pharmacokinetics of recombinant CD4-immunoglobulin G (rCD4-IgG) were evaluated in a phase 1 study with dose escalation. A total of 16 patients, 6 with AIDS and 10 with AIDS-related complex, were evaluated at two university-affiliated hospital clinics. rCD4-IgG was administered once weekly for 12 weeks to four patients each at doses of 0.03, 0.1, 0.3, and 1.0 mg/kg of body weight. Dosing was intravenous for two patients in the 1.0-mg/kg dose group and intramuscular for the remaining patients. Dosing was intravenous for two patients in the 1.0-mg/kg dose group and intramuscular for the remaining patients. Pharmacokinetic, toxicity, and immunologic variables were monitored with all patients. Administration of rCD4-IgG was well tolerated, with no important clinical or immunologic toxicities noted. No subjects required dose reduction or discontinuation of therapy due to toxicity. No consistent changes were seen in human immunodeficiency virus antigen levels in serum or CD4 lymphocyte populations. The volume of distribution was small, and compared with that of rCD4, the half-life of the hybrid molecule was markedly prolonged following intramuscular or intravenous administration. The rate and extent of absorption following intramuscular dosing were variable. Intramuscular administration of rCD4-IgG appears to be inferior to intravenous dosing from a pharmacokinetic standpoint, with lower peak concentrations and variable absorption. After intravenous administration, peak concentrations of rCD4-IgG in serum (20 to 24 micrograms/ml) that have shown antiviral activity in vitro against more sensitive clinical isolates of human immunodeficiency virus were achieved. The peak concentrations in serum after intramuscular administration were below these levels. Treatment with rCD4-IgG was well tolerated at the doses administered to patients in this study but did not result in significant changes in CD4 lymphocyte counts or p24 antigen levels in serum.

AIDS-Related Complex↗
PubMed1996

A controlled trial of nevirapine plus zidovudine versus zidovudine alone in p24 antigenaemic HIV-infected patients. The Dutch-Italian-Australian Nevirapine Study Group.

OBJECTIVES: Nevirapine is a non-nucleoside reverse transcriptase inhibitor of HIV-1 which exhibits synergy in vitro with zidovudine (ZDV) and also is active against ZDV-resistant HIV. We evaluated the activity and safety of nevirapine in combination with ZDV in patients receiving long-term ZDV therapy. METHODS: We conducted a randomized, open-label, controlled 28-week study of nevirapine (200 mg daily for 2 weeks followed by 200 mg twice daily for 26 weeks) and continued ZDV (500-600 mg daily) versus continued ZDV alone in 49 HIV-1 p24 antigenaemic patients with CD4+ lymphocyte counts < 500 x 10(6)/l and who had been treated with ZDV for at least 6 months. RESULTS: Addition of nevirapine to ZDV resulted in a significant and rapid reduction in circulating RNA load (mean, 0.65), a mean CD4+ lymphocyte rise of 34 x 10(6)/l, a reduction in serum beta 2-microglobulin and a median fall in immune complex dissociated p24 antigen levels of 69%. These changes remained statistically significant for 4, 4, 12 and at least 28 weeks, respectively. The principal adverse event due to nevirapine was a hypersensitivity reaction comprising rash with or without fever and mucositis in eight (32%) patients, which was dose-limiting in seven patients. CONCLUSION: Nevirapine exhibits significant although transient anti-HIV activity in ZDV-pretreated patients but its use is frequently associated with a hypersensitivity reaction.

Adult↗
PubMed1991

Pneumocystis carinii pneumonia associated with profound lymphopenia and abnormal T-lymphocyte subset ratios during treatment for early-stage breast carcinoma.

Two women with Stage II breast carcinoma treated with lumpectomy followed by breast irradiation and adjuvant chemotherapy developed Pneumocystis carinii pneumonia while receiving cytotoxic chemotherapy. Neither woman had evidence of immunosuppression before therapy. They both had profound lymphopenia, reversed CD4/CD8 ratios, and normal peripheral blood total leukocyte counts at the time of their infections. Both women were seronegative for human immunodeficiency virus type 1 and had no risk factors for such an infection. The patients' CD4 lymphocyte counts increased after chemotherapy for breast carcinoma was discontinued. Thus, it appears that the therapy they received may have caused severe T-lymphocyte mediated immunosuppression.

Adult↗
PubMed1994

Effect of splenectomy on HIV-related thrombocytopenia and progression of HIV infection in patients with severe haemophilia.

Between May 1983 and September 1991 eleven patients with severe haemophilia underwent splenectomy for HIV-related thrombocytopenia. The sustained complete remission rate (platelets > 100 x 10(9)/l) was 82% over a mean follow-up period of 54 months. The group was compared with 22 age-matched non-thrombocytopenic HIV seropositive haemophiliacs who had not undergone splenectomy. Both groups had equivalent use of factor concentrate and there was no significant difference between the groups in terms of anti-retroviral treatment. Analysis of clinical progression of HIV infection and CD4 positive lymphocyte (CD4+) counts, for the time since splenectomy, revealed no significant difference in progression of HIV infection in the splenectomized group compared with the control group. It is concluded that splenectomy is an effective treatment for HIV-related thrombocytopenia and has no adverse effect on the progression of HIV infection.

CD4-Positive T-Lymphocytes↗
PubMed1990

Coccidioidomycosis during human immunodeficiency virus infection. A review of 77 patients.

Through a retrospective review, we identified 77 previously unreported cases of coccidioidomycosis during HIV infection. Patients were classified into 1 of 6 categories based on their primary clinical presentation: 20 had focal pulmonary disease (Group 1), 31 had diffuse pulmonary disease (Group 2), 4 had cutaneous coccidioidomycosis (Group 3), 9 had meningitis (Group 4), 7 had extrathoracic lymph node or liver involvement (Group 5), and 6 has positive coccidioidal serology without a clinical focus of infection (Group 6). Coccidioidal serologies were positive on initial testing in 83% of the patients in whom such serologic testing was performed. Sera from 39% of patients were positive for TP antibodies while 74% had CF antibodies. Eleven of 12 seronegative patients had pulmonary disease (Group 1 or 2). Serologic results of other patients sent to a single reference laboratory were similar, with 26% positive for immunodiffusion TP antibodies and 79% positive for immunodiffusion CF antibodies. For the 77 patients in this study, the CD4-lymphocyte count was below 0.250 X 10(9) cells/L in 46 of the 55 patients who had this test performed, and a low CD4 count was significantly associated with mortality (p less than 0.01). At the time of follow-up, 32 of the 77 patients (42%) had died. There were significantly more deaths in those with diffuse pulmonary disease (Group 2) than in other groups (p less than 0.001). Amphotericin B, ketoconazole, fluconazole, and itraconazole were all used as antifungal therapies. Outcome could not be related to the therapy used. Of note, 3 patients developed coccidioidomycosis while receiving ketoconazole for other conditions.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1993

Zidovudine toxicity. Clinical features and management.

Zidovudine is a dideoxynucleoside analogue of thymidine. It acts by interfering with viral reverse transcriptase, thereby inhibiting human immunodeficiency virus (HIV) replication. Zidovudine has been shown in clinical trials to prolong survival of patients with acquired immune deficiency syndrome (AIDS) and advanced AIDS-related complex (ARC), and to delay progression to ARC or AIDS in patients with earlier disease. At the present time it is suggested that zidovudine be initiated when the CD4 lymphocyte count is less than 500 cells/mm3. Recent studies have suggested a delay in the development of AIDS in patients with CD4 counts over 500 cells/mm3, but ongoing studies will require confirmation. The adverse reactions associated with zidovudine have been well described. It appears that haematological toxicity is associated with both the dose and stage of disease. Anaemia may present more often within the first 3 months of therapy, whereas neutropenia can occur early or late. Mild headache and gastrointestinal intolerance may occur early and in some cases limit tolerance to the drug. A number of neurological adverse reactions have been reported rarely including seizures and dose-reduction encephalopathy. The most significant late adverse reaction is that of myopathy, which occurs in patients receiving zidovudine for more than 6 months. With careful monitoring, the adverse reactions of zidovudine are manageable and patient tolerance of the medication is acceptable.

Animals↗
PubMed2004

Rate of decline of absolute number and percentage of CD4 T lymphocytes among HIV-1-infected adults in Dar es Salaam, Tanzania.

OBJECTIVE: To determine the rate of decline of CD4 T lymphocytes among HIV-1-infected individuals. DESIGN AND SETTING: A prospective open cohort study of workers in three hotels in Dar es Salaam. METHODS: The workers were seen yearly during the study. CD4 T lymphocyte counts were determined using flow cytometry. The CD4 T-lymphocyte slopes were determined using a linear regression model. RESULTS: During the 9-year study period 682 subjects were selected for lymphocyte subset determinations. Of these, 94 HIV-1-seroprevalent (72%), 77 HIV-1-seroincident (67%) and 325 seronegative (75%) individuals had three or more CD4 T-cell determinations, and were used for calculations of CD4 cell slopes with a mean follow-up period of 71.4, 52.9 and 86.0 months, respectively. The median yearly decline of the CD4 T-lymphocyte counts and percentages among seroprevalent individuals was -21.5 cells/microl and -1.3%; among the seroincident individuals the median decline was -22.0 cells/microl and -1.5%. In seroincident individuals the mean duration to a CD4 T-lymphocyte level corresponding to a definition of AIDS was 13.3 years or 11.8 years for CD4 cell counts or percentages, respectively. HIV-1-seropositive subjects who died had significantly steeper CD4 cell slopes than those who survived. CONCLUSION: The rates of CD4 T-lymphocyte decline in HIV-1-infected individuals in our population are similar to those reported in Europe and north America.

Adult↗
PubMedDate not supplied

Cryptosporidiosis in HIV-seropositive patients.

The incidence of cryptosporidiosis in our unit has increased over the last 6 years, being diagnosed in approximately 5 per cent of all patients with HIV infection and in 21 per cent of those with AIDS, but a marked seasonal variation occurs. We have studied the course of the infection in 128 patients and identified four clinical patterns of disease: transient (28.7 per cent), chronic (59.7 per cent), fulminant (7.8 per cent) and asymptomatic (3.9 per cent). Transient disease occurred in patients with a wide range of CD4 lymphocyte counts, but was more common in less immunosuppressed patients. Fulminant disease, defined by the passage of more than 2 l of stool/day from the time of presentation, only occurred in patients with a CD4 count less than 50/mm3. This group had lost more than 7 kg in weight at presentation and more commonly had other intercurrent gastrointestinal infections. They survived for a median of only 5 weeks, compared with 20 weeks for those with chronic diarrhoea and 36 weeks for those with transient infection. The survival was unaffected by any treatment other than zidovudine. Cryptosporidiosis in HIV-infected individuals is a heterogeneous disease.

AIDS-Related Opportunistic Infections↗
PubMed1993

Predictors of rapid progression to AIDS in HIV-1 seroconverters.

OBJECTIVE: To determine whether at the time of HIV-1 seroconversion rapid progressors to AIDS and a low CD4+ count can be distinguished by the clinical presentation of primary HIV-1 infection and serological and immunological characteristics. DESIGN: Prospective cohort study on HIV-1 infection in homosexual men. SETTING: The Municipal Health Service, Amsterdam, The Netherlands. SUBJECTS: One hundred and eight men who seroconverted for HIV-1 during follow-up. MAIN OUTCOME MEASURES: Progression to AIDS and progression to a CD4+ lymphocyte count < 200 x 10(6)/l. RESULTS: Symptomatic primary HIV infection with fever and skin rash, absence of anti-HIV core and transient HIV p24 antigenemia were independent predictors of progression to AIDS at the time of HIV-1 seroconversion. A low CD4+ count immediately after seroconversion and the calendar year were independent predictors of progression to a low CD4+ count at the time of HIV-1 seroconversion. CONCLUSIONS: Even in the earliest stage of HIV-1 infection a small group of individuals at high risk for rapid progression to AIDS can be recognized by the clinical presentation of primary HIV infection, the presence of HIV p24 antigenaemia and the absence of a serological response to HIV core protein.

Acquired Immunodeficiency Syndrome↗
PubMed2004

Evidence for autoantibody-induced CD4 depletion mediated by apoptotic and non-apoptotic mechanisms in HIV-positive long-term surviving haemophilia patients.

It is believed that autoimmune phenomena and apoptosis contribute to CD4 depletion. We investigated 11 long-term (>20 years) HIV-infected haemophilia patients and 10 healthy controls. Using four-colour-fluorescence flow cytometry, we studied the proportions of CD3+CD4+ and CD3+CD4- blood lymphocytes that were CD95+, CD95L+, immune complex+ (IC+, consisting of IgM, IgG, C3d and/or gp120), and were viable or non-viable (propidium iodide+ = PI+). In addition, we studied viability of CD4+IgG+ patient lymphocytes using the apoptosis marker annexin and the permeability indicator 7-amino actinomycin D (7-AAD). HIV+ patients had a higher proportion of CD3+CD4+IgG+PI+ lymphocytes than healthy controls (median: 3.7%versus 0.3%; P = 0.00001). These non-viable IgG-coated lymphocytes might have been killed in vivo by ADCC or complement lysis; 9.1% of the circulating CD3+CD4+ blood lymphocytes were IgG+PI- (controls: 2.5%; P = 0.001). These viable IgG-coated lymphocytes might be targets for phagocytosis or anti-CD95 autoantibody-mediated apoptosis. Because HIV+ patients and healthy controls had similar proportions of PI+ or PI- CD3+CD4+ lymphocytes that carried CD95L on the surface, and because CD3+CD4+CD95L+ cells that were IgG+, C3d+ and/or gp120- were increased in HIV+ patients, the role of CD95L-induced apoptosis in long-term HIV-infected haemophilia patients remains unclear. The findings that HIV+ patients had higher proportions of CD3+CD4+CD95+ (PI+: 6.5%versus 1.4%; P = 0.00002; PI-: 55.8%versus 44.4%; P = 0.04) blood lymphocytes and that the proportion of CD4+IgG+Annexin+7-AAD- blood lymphocytes was associated inversely with peripheral CD4 counts (r = -0.636; P < 0.05) suggest that attachment of IgG to CD4+ blood lymphocytes (anti-CD95?) induces in some lymphocytes apoptosis with subsequent depletion of these IgG-coated apoptotic CD4+ lymphocytes from the circulation. We found supporting evidence for the contention that autoantibody-induced apoptotic and non-apoptotic mechanisms contribute to CD4 depletion in long-term HIV-infected haemophilia patients.

Adolescent↗
PubMed1996

The distribution of immunocompetent cells in the genital tract of HIV-positive women.

OBJECTIVE: To study the distribution of immunocompetent cells in the female lower genital tract and to determine whether it is altered in HIV infection. METHODS: Colposcopically directed cervical biopsies were taken in the premenstrual phase of 10 HIV-positive women with sexually acquired infection, and matched HIV-negative controls. Peripheral blood was collected from the HIV-infected group for immune studies. Histological, immunohistochemical and double immunofluorescence techniques were applied to the biopsies to reveal immunocompetent cell distribution. Comparisons were made between the immune cell populations in the cervix in the HIV-positive and negative groups, and between the cervix and peripheral blood in the HIV-positive group. RESULTS: Cervical biopsies from HIV-positive women had significantly reduced Langerhans and plasma cell counts in the submucosa, but increased T lymphocyte counts compared with the HIV-negative group. There was an increase in CD8+ lymphocyte numbers in cervical biopsies of HIV-positive women, causing an inversion of the CD4/CD8 ratio. The majority of these CD8+ cells were 'memory' (CD45RO+) cells, with reduced proportions expressing perforin (cytoplasmic cytolytic granules) and TIA-1 (cytolytic granule-associated protein). Natural killer (CD57) cell markers were not detected. The levels of CD8+ cells expressing Bcl-2 (a gene product inhibiting cell apoptosis) in HIV-positive women with relatively high peripheral CD4 lymphocyte cell counts was higher than in HIV-negative women, but these levels fell with declining CD4 lymphocyte counts (< 300 x 10(6)/1). The reduction in CD4/CD8 ratio in the cervix occurred even with relatively high peripheral CD4 counts. CONCLUSIONS: HIV disease is associated with alterations in the proportions of immunocompetent cells in the cervix. There is an increase in CD8+ T-lymphocytes and evidence of reduced cytolytic capacity; thus, CD8+ cells may lack the ability to respond to viral infection. Reduction in Langerhans' and plasma cells may reflect loss of signals from CD4+ T cells. These findings may, in part, explain why HIV-infected women are susceptible to recurrent fungal and viral infections, even when peripheral immune function is intact. Further studies of immune cell function are urgently required to further elucidate these findings.

Adult↗
PubMed1999

Soluble tumor necrosis factor receptor type II (sTNFRII) in HIV-infected patients: relationship with the plasma level of HIV-1 RNA.

The value of soluble receptor for tumor necrosis factor type II (sTNFRII) as a strong and early predictor of HIV disease progression was suggested. Recently it has been reported that sTNFRII may provide an indication of the HIV load. In this work we focused on the relationship between sTNFRII and HIV burden in 95 HIV-1+ patients without AIDS grouped according to the 1993 classification of the CDC as group A, n = 55, and group B, n = 40. Compared with healthy controls, higher values of sTNFRII were obtained in all groups of HIV-1 infected patients (P < 0.001), but we found no inverse correlation between sTNFRII and CD4+ lymphocyte counts in CDC group A and B of the disease, and no correlation with log RNA copy number in patients with CD4 T-cell counts > 499/microl. A correlation was obtained between sTNFRII and the viral load in patients with CD4 T-cell counts ranging from 200 to 499/microl, but only in CDC group B patients (P < 0.01, n = 26). There was no correlation between the variations of sTNFRII and HIV-1 RNA levels in 19 CDC group A and 15 CDC group B clinically stable patients in the course of a short follow up. The plasma level of sTNFRII do not appear as a valuable surrogate marker of the plasma level of HIV-1 RNA in patients. Further investigations are needed to define the mechanism of the raised level of sTNFRII in HIV-1 infected patients.

Adult↗
PubMed1999

Lower genital tract infections among HIV-infected and high-risk uninfected women: findings of the Women's Interagency HIV Study (WIHS).

BACKGROUND AND OBJECTIVES: Few comparisons of factors associated with sexually transmitted diseases (STDs) and HIV are available for representative samples of American women. GOAL OF THE STUDY: To compare factors associated with STDs in a large sample of women infected with HIV and women not infected with HIV. STUDY DESIGN: A cross-sectional analysis of STDs in 2,058 women seropositive (HIV+) for HIV and 567 women seronegative (HIV-) for HIV. RESULTS: HIV + women were more likely than HIV- women to report previous STDs, with the exceptions of chlamydia and bacterial vaginosis. Both HIV status and CD4 lymphocyte count were associated with evidence of genital ulcerations, warts, and vaginal candidiasis (p <0.001 for all). HIV- women were more apt to report recent vaginal intercourse (p <0.001), a factor that was independently associated with the occurrence of bacterial and protozoan infections. CD4 lymphocyte depletion was the factor most closely associated with the expression of chronic viral infections. CONCLUSIONS: In this North American cohort, HIV+ women were more likely than HIV- women to report previous genital tract infections and symptoms. However, the HIV+ women reported less recent sexual activity and few gonococcal or chlamydial infections.

Adolescent↗
PubMed1995

Zalcitabine. Clinical pharmacokinetics and efficacy.

Zalcitabine (ddC) was the first drug to be approved under the US Food and Drug Administration's (FDA's) accelerated drug approval process. Zalcitabine is a potent nucleoside analogue inhibitor of reverse transcriptase used in the treatment of HIV infection. It is approximately 10-fold more potent than zidovudine (AZT) on a molar basis in vitro. Zalcitabine is well absorbed orally and reaches maximal plasma concentrations within 1 to 2 hours. In humans it is mainly eliminated by renal excretion of unchanged drug, and patients with renal failure may exhibit a prolonged half-life. A variety of clinical trials have evaluated the efficacy of zalcitabine based on improved survival and decreased frequency of opportunistic infections and on a surrogate marker of HIV disease, the CD4 count, or the concentration of an antigen associated with HIV, p24. Alternating zalcitabine therapy with zidovudine therapy was associated with increased CD4+ lymphocyte counts and reduced plasma p24 antigen levels. Zalcitabine can cause peripheral neuropathy (in 17 to 31% of patients), which is dose-related and is completely reversible when the drug is discontinued. Zalcitabine will continue to play a role in chemotherapeutic approaches to HIV.

Animals↗