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Biomedical subjects

Christine Mauck

Publications and source records attributed to Christine Mauck.

13 recordsLinked to original sources
PubMed2006

Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women.

OBJECTIVES: Few studies of topical microbicides have assessed their safety in HIV-infected women. We conducted this study to evaluate the safety and acceptability of 6% cellulose sulfate (CS) gel as a vaginal microbicide in sexually abstinent and active HIV-infected women. METHODS: Fifty-nine HIV-infected women were enrolled in a randomized double-blind placebo-controlled study comparing 6% CS to placebo gel used for 14 days. Sexually abstinent women applied gel once or twice daily and sexually active women used gel once daily. RESULTS: CS gel was safe with no reported severe or life-threatening adverse events (AE). Thirty-nine (66%) of the participants experienced urogenital AE judged as probably or possibly related to gel. The majority (51%) of these participants reported only mild events. Fewer women (62%) who used CS experienced urogenital AE than those assigned to placebo gel (70%) (P = 0.59). Eleven (19%) women experienced intermenstrual bleeding judged to be probably or possibly related to gel use (four in the CS and seven in the placebo gel group). There was no increase in AE by frequency of gel use or sexual activity with the exception of abdominal/pelvic pain which was noted more frequently with twice daily use among sexually abstinent women. Women and men found the gel highly acceptable. CONCLUSIONS: This Phase I study demonstrated that CS vaginal gel was safe, well tolerated and acceptable by HIV-infected women and their male partners. Thus, further development of CS is warranted as a potential method to prevent HIV transmission and acquisition.

Abdominal Pain↗
PubMed2006

Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study.

BACKGROUND: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. METHODS: We performed a multicenter, Phase I, placebo-controlled, randomized study to evaluate the genital toxicity of CS. Two cohorts of healthy women used 3.5 ml of 6% CS gel or 3.5 ml of K-Y Jelly, vaginally, bid, for 14 days. The first cohort was sexually abstinent, and the second cohort was sexually active. RESULTS: CS was associated with only a slightly higher odds ratio (OR) of symptoms of minor urogenital irritation compared to the inactive lubricant K-Y Jelly (OR=2.02, 95% confidence interval=0.90-4.53). In addition, there were minor shifts in some genital flora, but there was no evidence of greater inflammation as evidenced by few colposcopic findings, decreased influx of polymorphonuclear cells and minimal changes in proinflammatory cytokines. Moreover, both products appeared acceptable to most women. Product leakage was identified as more of a problem in sexually abstinent women, but less so in women using the product for sexual intercourse, as would be the case in actual practice. CONCLUSION: CS was safe for twice-daily use for 14 days. CS is appropriate for future studies in effectiveness trials.

Adolescent↗
PubMed2006

Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product.

BACKGROUND: ACIDFORM is a microbicidal and contraceptive candidate with strong buffering capacity. METHODS: This was a Phase I blinded, randomized and crossover clinical study on two products, ACIDFORM and a commercial nonoxynol-9 (N-9) product (2%), evaluating their vaginal safety in 20 couples aged between 19 and 45 years. The women had regular menses, underwent previous tubal ligation, were not breast-feeding, had no vaginal sign and symptom and were in a stable partnership; both partners had no previous STI. Colposcopy, vaginal microbiology, inflammation markers and subject complaints were studied after coitus. Women were randomly assigned sequentially to receive ACIDFORM 0-30 min (0-30 min before intercourse), ACIDFORM 8-10 h (8-10 h before intercourse) or N-9 0-30 min after a control cycle. RESULTS: Mild/moderate vulvar irritation was observed in five postcoital test colposcopies, burning and pruritus were reported in six treated cycles and non-irritation-related symptoms were found in five cycles with different treatments. No difference in vaginal pH, Nugent scores, H2O2-producing lactobacillus or leukocytes and interleukin 6 in the cervicovaginal lavage was found between the treatment and control cycles. CONCLUSIONS: ACIDFORM appears to be safe for clinical use once a day. There is a potential spermicidal-microbicidal role for ACIDFORM as a vaginal flora helper or as a vehicle for products, except N-9.

Adult↗
PubMed2005

Male tolerance of ACIDFORM gel.

BACKGROUND: ACIDFORM gel is being studied as a vaginal contraceptive and microbicide. This study was conducted to make certain that males will not be subjected to an unacceptable risk of penile irritation as a result of exposure to the product in future studies. METHODS: This was a randomized, double-masked, single-center Phase I study in circumcised and uncircumcised men to assess penile irritation, safety and acceptability of seven consecutive doses of ACIDFORM gel compared with K-Y Jelly Personal Lubricant. Each participant was instructed to apply 2 mL of the study product to his penis at bedtime, to wash it off 6-10 h later and to record any symptoms on a diary card. At the follow-up visit, a genital examination was performed and participants were asked about adverse events (AEs) and completed an acceptability questionnaire. RESULTS: Of the 36 men enrolled, 2 out of 24 (8.3%) ACIDFORM gel users and 5 out of 12 (41.7%) K-Y Jelly users reported genital symptoms. Genital examination findings were observed in 2 out of 24 (8.3%) ACIDFORM gel users and in 1 out of 12 (8.3%) K-Y Jelly users. All product-related AEs were considered mild except for two in the K-Y Jelly group. Both products were acceptable. CONCLUSION: ACIDFORM gel applied to the penis for seven consecutive days appears to be at least as safe and well-tolerated as the marketed lubricant K-Y Jelly among healthy low-risk men.

Adult↗
PubMed2005

Vaginal distribution of two volumes of the novel microbicide gel cellulose sulfate (2.5 and 3.5 mL).

This was a blinded crossover study to determine the in vivo distribution of 2.5 and 3.5 mL of 6% cellulose sulfate gel. This potential vaginal microbicide was mixed with dilute gadolinium chelate and inserted into the vagina. Magnetic resonance imaging was performed at baseline and repeated after 5, 20, 35 and 50 min with subjects either resting or ambulating between data acquisitions. Use of 2.5 mL with no ambulation gave low linear spread (53.1% of vaginal length) and surface contact (61.7%) at 50 min. Using 3.5 mL of gel with ambulation improved linear spread (84.5%) and surface contact (85.9%) of the gel in the same time interval without significant leakage. Most linear spreading took place in the first 5 min after insertion, although lateral spreading continued to increase with time especially when ambulation took place. Leakage and gel was not a significant problem at either volume.

Administration, Intravaginal↗
PubMed2004

Vaginal microbicides: a novel approach to preventing sexual transmission of HIV.

The AIDS epidemic continues its unrelentless expansion. According to the Joint United Nations Programme on HIV/AIDS, there are more than 40 million people living with HIV, and more than 15,000 new infections occur every day. One approach to curbing HIV is the development of topical microbicidal agents or microbicides. These are compounds designed to protect the body's mucosal surfaces from infection by sexually transmitted disease-causing pathogens, including HIV. Several candidates are in preclinical stages; however, only a handful have been tested in humans for safety, and even fewer are ready for clinical efficacy trials. In this update, we describe microbicide research and development, including preclinical screening algorithms, ideal properties, compounds in the pipeline, and future prospects. This review is based on a previous work, which has been updated to contain new information, especially regarding microbicide candidates in preclinical and clinical stages of development.

Administration, Intravaginal↗
PubMed2004

Diaphragms in clinical trials: is clinician fitting necessary?

BACKGROUND: The need for fitting a contraceptive diaphragm has recently been questioned in the context of upcoming trials in which the ability of the diaphragm to prevent sexually transmitted infections will be tested. Being able to provide the same size device to all women would greatly simplify supplying the device and training the clinicians, provided that it does not compromise effectiveness. METHODS: Data from studies of Lea's Shield and FemCap, in which all women were sized for a standard diaphragm and half were randomized to use it during the studies, were reanalyzed to determine if it was feasible to give all women in a barrier study the same size diaphragm or, alternatively, to determine if diaphragm size could be predicted using an algorithm of one or more parameters. RESULTS: If all women received a size 70 diaphragm, rather than being fitted by a clinician, 33.2% would receive the same size that they would have received if they had been fitted by a clinician. If the definition of a "correct" fit were broadened to include one size larger or smaller than what the clinician would have prescribed, 78.0% would be "correctly" fitted. Using an algorithm that considered parity, body weight and other factors did not improve results. CONCLUSION: It would be acceptable to conduct a trial in which all women receive a size 70 diaphragm, provided that all women are sized; that safety, effectiveness and acceptability are closely monitored and that study results are stratified by the diaphragm size determined by clinician fitting. It would also be informative to use sized diaphragms as the comparator in studies of new single-size devices.

Body Weight↗
PubMed2004

Postcoital testing after the use of a bio-adhesive acid buffering gel (ACIDFORM) and a 2% nonoxynol-9 product.

ACIDFORM is a gel already shown to be safe in vaginal use during six consecutive days through colposcopic observation. A randomized, blinded, crossover study was carried out to compare the spermicidal effect of ACIDFORM to that of a commercial 2% nonoxynol-9 (N-9) product. Twenty sexually active, sterilized women, aged 19-45 years, with regular cycles, normal gynecological exam, no previous sexually transmitted infection (STI) and stable partner willing to undergo four postcoital tests (PCTs) at midcycle during four different menstrual cycles, were enrolled in the study. Known allergy to N-9 or ACIDFORM, oligospermic partner, chronic diseases, use of hormones, previous treatment for STI or presence of STI at screening tests were criteria for exclusion. ACIDFORM or N-9 product administered 0-30 min precoitus or ACIDFORM given 8-10 h precoitus significantly reduced the mean number of progressively motile sperm compared to control cycles (0.19, 0.07, 0.75 vs. 17.94, respectively, p<.05, Wilcoxon test). All treated cycles had five or fewer progressively motile sperm in midcycle cervical mucus, confirming in vivo the spermicidal effect of ACIDFORM previously observed in vitro and in animal models.

Administration, Intravaginal↗
PubMed2002

Use of MRI to determine the in vivo position of a silicone vaginal barrier contraceptive device.

This study was performed to determine the location of a silicone rubber vaginal barrier contraceptive device, the Lea's Shield, in vivo. Two women, one parous and one nulligravid, were enrolled in the study. Surface coil, multiplanar Magnetic Resonance Imaging (MRI) was performed immediately following insertion of the contraceptive device, and was repeated following 35-40 min of normal ambulation by the participant.The contraceptive device was markedly hypointense to pelvic structures on both T1 and T2 weighted images. Its position within the vagina and relationship to the cervix were readily identifiable on MR images. The device was located in the upper vagina and completely covered the cervix in both patients. The valve appeared closed, and there was no apparent pressure on the urethra. The position was not altered by ambulation. In conclusion, MRI was a reproducible and rapid means for noninvasively determining the intravaginal location and orientation of a barrier contraceptive device. After insertion, the Lea's Shield occupies the upper vagina and completely covers the cervix.

Adult↗
PubMed2002

A randomized comparative study on mifepristone alone and in combination with tamoxifen for emergency contraception.

The purpose of the clinical study was to compare the efficacy and side effects of 10 mg of mifepristone alone (Group 1) and with 20 mg of tamoxifen (Group 2) for emergency contraception, especially as used within 72-120 h after coitus. Four-hundred female volunteers with one act of unprotected intercourse or contraception failure (200 cases in each group) were recruited and completed the study. There were 198 women treated < 72 h after coitus (100 in Group 1 and 98 in Group 2), whereas the remaining 202 patients were treated between 72-120 h (100 in Group 1 and 102 in Group 2). In total, four pregnancies occurred; one treated < 72 h in each group, two between 72-120 h in Group 1. Efficacy for prevention of unwanted pregnancy by Trussell method is 84% for Group 1, and 95% for Group 2, and which is not significantly different between the two groups and even subgroups. The side effects (15.5% for Group 1 and 14.5% for Group 2) and changes in menstruation were infrequent and mild in both groups. Further studies should be conducted to determine whether tamoxifen combined with mifepristone for emergency contraception is more effective as compared with mifepristone alone.

Adult↗
PubMed2001

An Update on Vaginal Microbicides.

In response to an increasing prevalence of sexually transmitted diseases, especially AIDS, efforts to prevent further infections have been heightened. One of those approaches has been the development of topical microbicidal agents or microbicides. These are compounds designed to protect the body's mucosal surfaces from infection by sexually transmitted disease-causing pathogens. Numerous candidates are currently in preclinical stages; however, only a handful have been tested for safety, and even fewer are ready for clinical efficacy trials. In this update, we describe some of the specific features of microbicide research and development, including preclinical screening algorithms, candidate's ideal properties, examples of compounds presently in the pipeline, and future prospects.

Journal Article↗