Skip Navigation LinksHome > January 7, 2000 - Volume 14 - Issue 1 > Safety of multiple daily applications of COL-1492, a nonoxyn...
AIDS:
Epidemiology and Social: Concise Communication

Safety of multiple daily applications of COL-1492, a nonoxynol-9 vaginal gel, among female sex workers

Van Damme, Luta; Chandeying, Verapolb; Ramjee, Gitac; Rees, Helend; Sirivongrangson, Pacharae; Laga, Mariea; Perriëns, Josf; on behalf of COL-1492 Phase II Study Group

Free Access
Article Outline
Collapse Box

Author Information

From the aInstitute of Tropical Medicine, Antwerp, Belgium, the bPrince of Songkla University, Hat Yai, Thailand, the cCentre for Epidemiological Research (CERSA), Durban, the dReproductive Health Research Unit, Johannesburg, Republic of South Africa, eMinistry of Public Health, VD Division, Bangkok, Thailand and fUNAIDS, Geneva, Switzerland. *See Appendix.

Correspondence to Lut Van Damme, STD/HIV Research and Intervention Unit, Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium.

Received: 8 October 1999; revised: 23 September 1999; accepted: 27 October 1999.

Collapse Box

Abstract

Rationale: COL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a potential microbicide. As part of an effectiveness trial, an initial toxicity study was conducted.

Objectives: The main objective of the reported study was the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a number of times each day by female sex workers.

Methods: This was a randomized, placebo-controlled triple-blinded trial among female sex workers. The participants were asked to use the product for each vaginal sexual act. At each monthly visit a gynaecological examination with sexually transmitted disease sampling and colposcopy was performed. Venous blood was drawn for syphilis and HIV serology. All women received intensive counselling on condom use. Male condoms and sexually transmitted disease treatment were given free of charge.

Results: Only blinded results on the colposcopic examinations are reported. The incidence of lesions with or without an epithelial disruption was low: 0.06 and 0.29, respectively, per 100 woman–days in group A; 0.09 and 0.26 respectively per 100 woman–days in group B. There was no significant difference between the two arms.

Conclusion: The multiple daily use of COL-1492 by female sex workers did not show an increase of local toxicity over that of a placebo. Colposcopy was discontinued in the autumn of 1997 in accordance with a Data Safety Monitoring Board decision. In the currently ongoing effectiveness trial the assessment of the product's toxicity continues to be monitored by simple visual examination.

Back to Top | Article Outline

Introduction

For several years nonoxynol-9 (N-9) has received a lot of attention as a potential microbicide. It acts by disrupting the membranes of cells, viruses and bacteria. N-9 has an in vitro activity against HIV and other sexually transmitted disease (STD) pathogens [1–6] Although most in vivo data show a protective effect against Neisseria gonorrhoeae and Chlamydia trachomatis[7–11] the data on in vivo anti-HIV effectiveness are not conclusive. Two cohort studies showed a protective effect of N-9 among consistent users [12,13] One randomized controlled trial among female sex workers in Kenya showed an increased HIV incidence among women using a 1000 mg N-9 sponge compared with placebo users [14] However this study has been criticized for methodological reasons [15] A randomized controlled trial with a vaginal film containing 70 mg N-9 among Cameroonian female sex workers showed no effect, either harmful or beneficial, on HIV, N. gonorrhoeae or C. trachomatis[16] Despite these results, an effectiveness trial with COL-1492, using a 52.5 mg N-9-containing vaginal gel, is continuing with the justification that a different formulation may give a better availability of N-9 in the vagina and that a lower N-9 concentration may be associatied with less toxicity. The trial started with an intensive toxicity monitoring phase using colposcopy. The results of these colposopic evaluations are reported here.

Back to Top | Article Outline

Methods

The reported study is part of a larger randomized, placebo-controlled, triple-blind trial among female sex workers to assess the product's effect in the prevention of heterosexual vaginal HIV infection and other STDs. Participants were recruited through the Venereal Disease Unit of the Ministry of Public Health, Bangkok, Thailand; the Prince of Songkla University, Hat Yai, Thailand; the Centre for Epidemiological Research (CERSA), Durban, South Africa and the Reproductive Health Research Unit, Johannesburg, South Africa. The technical coordination was carried out by the Institute of Tropical Medicine, Antwerp, Belgium. The main trial sponsor was UNAIDS, Geneva, Switzerland. The study was approved by all local and national ethical review boards.

HIV-seronegative female sex workers who volunteered could be enrolled if they had at least five partners per week; were participating in a 100% condom-use programme; were above the local legal adult age and were willing and able to comply with the study protocol. They were excluded if they had a genital ulcer, abrasion or clinical STD; required any long-term treatment; used intravenous drugs, crack or cocaine; were pregnant or wished to become pregnant; were allergic to latex or nonoxynol-9 or were using a vaginal spermicide. A separate randomization was carried out for each centre.

COL-1492 gel (marketed in the United States as the spermicidal gel Advantage S®, Columbia Laboratories, New York, New York, USA) contains 3.5% (52.5 mg) nonoxynol-9; other constituents include polycarbophil, a polymer with bio-adhesive properties. The placebo gel contained the same ingredients with the exception of nonoxynol-9. Both were packed in single-dose, disposable plastic applicators designed to deliver 1.5 g gel. COL-1492 and the placebo were provided by Columbia Laboratories (Paris, France).

At each visit a gynaecological examination with STD sampling and a colposcopic evaluation were carried out. Blood was drawn for HIV and syphilis serology. Participants were counselled on HIV testing and safe sex. At screening concise information on the study was given. Oral informed consent for the screening procedures was obtained. Eligible women were enrolled within 28 days after their screening. At the enrolment visit comprehensive information was given and written informed consent obtained. Whenever an STD was diagnosed, treatment was given free of charge. Women received the required quantity of study product and male condoms. They were asked to use the male condom for every sexual act and to apply the gel for every vaginal act if they had cleaned their vagina after the last intercourse.

The main outcomes of the reported sub-study were lesions revealed by colposcopy performed according to the modified WHO manual on colposcopy (i.e. no acetic acid, iodine or green filter were used) [17]

To have an 80% chance of detecting a difference of 15% in incidence of colposcopic findings between the two groups, a sample size of 150 subjects was needed (α = 0.05, one-sided), or 75 subjects in each treatment group. An intention-to-treat analysis was performed on data of women with at least one colposcopic examination. The analysis was focused on the first five visits. For each of these visits the sample size was sufficient. A preliminary investigation to study the relationship between presence of a lesion and study drug was done by construction of 2 × 2 tables for each of these five visits. In order to control for confounding, logistic regression was performed comparing the treatment groups with respect to the presence of colposcopic lesions at these visits. Finally, a Cox's proportional hazards model was used to compare the incidence of lesions in each treatment group. A P-value of 0.05 was regarded as statistically significant.

Only the blinded results on colposcopy will be presented, because the other outcomes (gynaecological signs, visual pelvic examination, STDs and acceptability) are part of the phase III endpoints.

Back to Top | Article Outline

Results

Study population

A total of 320 women had at least one colposcopic evaluation: 158 in group A, 162 in group B. At baseline all characteristics were similar in both arms as summarized in Table 1. Women in Hat Yai had on average fewer clients (mean of 1.6) than women in the other centres. There was a major difference between the centres with regard to condom use. In Bangkok all women reported more than 75% condom use, in Durban 63% used condoms for less than 25% of their sexual acts and 91% for less than 50%, whereas in Hat Yai and Johannesburg almost all women (98 and 91% respectively) used condoms for more than half of their sexual acts.

Table 1
Table 1
Image Tools

The mean daily gel use was 1.2 (range, 0–9.9) and 1.3 applicators (range, 0–5.9) in groups A and B respectively.

Back to Top | Article Outline
Colposcopy results

At baseline around 10% of participants in both groups had an abnormality on colposcopy. These women were excluded from the survival analysis.

During product use few lesions as described in the WHO manual were observed. In group A five ulcers occurred in the vagina and on the external genitalia. In group B seven ulcers were diagnosed. All ulcerations had disappeared at the next visit. Abrasions were diagnosed on the cervix and the external genitalia. These had also healed at the next visit. In lesions without epithelial disruption, erythema occurred most frequently and was mostly observed on the cervix. In logistic regression, controlling for centre, there was no difference at any visit (up to week 12) between the treatment groups for the probability of having a lesion.

The incidence of colposcopic lesions was low with no difference between group A and B (Table 2), and this for lesions with or without epithelial disruption. In both groups, the chance of having a lesion increased with an increase in the mean daily use of the product (P < 0.001). No other factors could be associated with the observation of lesions.

Table 2
Table 2
Image Tools
Back to Top | Article Outline

Discussion

The reported data show that the multiple daily use of COL-1492, a 52.5 mg N-9 gel, by female sex workers is non-toxic. The incidence of lesions with epithelial disruption was low, 0.06 and 0.09/100 woman–days in groups A and B, respectively. Lesions without an epithelial disruption occurred at similar rates in both groups.

At the present time there is some hesitation and doubt about the role of colposcopy in microbicide trials. Researchers were concerned about the potential toxicity of spermicides, and as a consequence a possible increased risk of HIV infection [14,18] A consensus was reached that before effectiveness trials could start, the safety of a product should be established. One tool for monitoring vaginal toxicity is colposcopy. It is a good light source, gives an enlarged view, the vascular pattern can be assessed and photographs can be taken. An international team developed the WHO manual with a primary objective of defining the standardization of colposcopy in the evaluation of vaginal products [17] However, researchers are now aware of some limitations to colposcopy. Firstly, it is not clear how one should interpret lesions without an epithelial disruption. Do they enhance HIV infectivity and/or infectiousness? Therefore the relevance of recording them has been questioned. Secondly, lesions with an epithelial disruption, which are likely to enhance HIV transmission in analogy with ulcerative STDs [19,20] can be seen with the naked eye. Thirdly, implementing and standardizing colposcopy in the field is difficult. Fourthly, no association between colposcopic and histologic findings has been established so far [21] In January 1999 the Contraceptive Research and Development Program (CONRAD) organized a meeting on colposcopy in microbicide trials. Among other subjects, a revision of the WHO manual was discussed. The main changes proposed were dropping the use of acetic acid, a green filter and a high magnification. Colposcopy was defined as `a magnified visualization of the cervix and vagina' for which the use of a colposcope is not necessary as long as there is an ability to magnify between 4× and 10×, a self-contained light source and a bi- or monocular visual tool.

In the trial presented here, colposcopy was discontinued in the autumn of 1997. Together with the effect on HIV infection and other STDs, the toxicity of the product continues to be assessed through simple visual examination.

Back to Top | Article Outline

Acknowledgements

The authors would like to thank all the study participants, the staff and the monitors in each centre, Tessa James for correcting the manuscript and Yvette Jacob for the administrative support. The analysis on colposcopic findings was performed by Veerle Vandersmissen, Institute of Tropical Medicine, Antwerp, Belgium.

Back to Top | Article Outline

References

1. Malkovsky M Newell A Dalgleish AG Inactivation of HIV by nonoxynol-9. Lancet 1988 1 (8586)645.645.

2. Bourinbaiar AS Fruhstorfer EC The efficacy of nonoxynol-9 from an in vitro point of view. AIDS 1996 10558.558.

3. Patton DL Wang S Kuo C In vitro activity of Nonoxynol-9 on HeLa 229 Cells and primary monkey cervical epithelial cells infected withChlamydia trachomatis. Antimicrob Agents Chemother 1992 361478–1482.

4. Hicks DR Martin LS Getchell JP et al Inactivation of HTLV-III/LAV-infected cultures of normal human lymphocytes by nonoxynol-9 in vitro. Lancet 1985 21422–1423.

5. Benes S McCormack WM Inhibition of growth ofChlamydia trachomatisby Nonoxynol-9in vitro. Antimicrob Agents Chemother 1985 27724–726.

6. Harrison C Chantler E The effect of nonoxynol-9 and chlorhexidine on HIV and spermin vitro. Int J STD AIDS 1998 992–97.

7. Weir SS Feldblum PJ Zekeng L Roddy RE The use of nonoxynol-9 for protection against cervical gonorrhea. Am J Public Health 1994 84910–914.

8. Niruthisard S Roddy RE Chutivongse S Use of nonoxynol-9 and reduction in rate of gonococcal and chlamydial cervical infections. Lancet 1992 3391371–1375.

9. Rosenberg MJ Rojanapithayakorn W Feldblum PJ Higgins JE Effect of the contraceptive sponge on chlamydial infection, gonorrhea, and candidiasis. JAMA 1997 2572308–2312.

10. Louv WC Austin H Alexander WJ Stagno S Cheeks J A clinical trial of nonoxynol-9 for preventing gonococcal and chlamydial infections. J Infect Dis 1988 158518–523.

11. Cook RL Rosenberg MJ Do spermicides containing nonoxynol-9 prevent sexually transmitted infections? Sex Transm Dis 1998 25144–150.

12. Hira SK Feldblum PJ Kamanga J Mukelabai G Weir SS Thomas JC Condom and nonoxynol-9 use and the incidence of HIV infection in serodiscordant couples in Zambia. Int J STD & AIDS 1997 8243–250.

13. Zekeng L Feldblum PJ Oliver RM Kaptue L Barrier contraceptive use and HIV infection among high-risk women in Cameroon. AIDS 1993 7725–731.

14. Kreiss J Ngugi E Holmes KK et al Efficacy of nonoxynol-9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. JAMA 1992 268477–482.

15. Stone KM Peterson HB Spermicides, HIV, and the vaginal sponge. JAMA 1992 268521–523.

16. Roddy RE Zekeng L Ryan KA Tamoufe U Weir SS Wong EL A controlled trial of nonoxynol-9 film to reduce male-to-female transmission of sexually transmitted diseases. New Engl J Med 1998 339504–510.

17. WHO Global Programme on AIDS, Geneva, Switzerland. Manual for the standardization of colposcopy for the evaluation of vaginally administered products. WHO/GPA/RID/CRD/95. 10.

18. Goeman J Ndoye I Sakho LM et al Frequent use of menfegol spermicidal vaginal foaming tablets associated with a high incidence of genital lesions. J Infect Dis 1995 1711611–1614.

19. Wasserheit JN Epidemiological synergy: interrelationships between Human Immunodeficiency Virus infection and other sexually transmitted diseases. Sex Transm Dis 1992 1961–77.

20. Laga M Nzilambi N Goeman J The interrelationship of sexually transmitted diseases and HIV infection : implications for the control of both epidemics in Africa. AIDS 1991 5(suppl 1)S55–S63.

21. Stafford MK Cain D Rosenstein I et al A placebo-controlled, bouble-blind prospective study in healthy female volunteers of dextrin sulphate gel. J Acquir Immune Defic Syndr Hum Retrovir 1997 14213–218.

Back to Top | Article Outline
Appendix
The COL-1492 phase II study group

Institute of Tropical Medicine, Antwerp, Belgium: Lut Van Damme, Eddy Van Dyck, Marie Laga; Prince of Songkla University, Hat Yai, Thailand: Verapol Chandeying; the Centre for Epidemiological Research (CERSA), Durban, RSA: Salim S. Abdool Karim, Gita Ramjee, Neetha Morar; Reproductive Health Research Unit, Johannesburg, RSA: Helen Rees, Kim Dickson, Audrey Pettifor, Patience Ndaba, Carol Richards; Ministry of Public health, VD Division, Bangkok, Thailand: Pachara Sirivongrangson, Somchai Niruthisard; UNAIDS, Geneva, Switzerland: Jos PerriMns. Cited Here...

Cited By:

This article has been cited 45 time(s).

Biology of Reproduction
Seminal Plasma Induces Prostaglandin-Endoperoxide Synthase (PTGS) 2 Expression in Immortalized Human Vaginal Cells: Involvement of Semen Prostaglandin E2 in PTGS2 Upregulation
Joseph, T; Zalenskaya, IA; Sawyer, LC; Chandra, N; Doncel, GF
Biology of Reproduction, 88(1): -.
ARTN 13
CrossRef
Plos Medicine
South Africa's experience of the closure of the cellulose sulphate microbicide trial
Ramjee, G; Govinden, R; Morar, NS; Mbewu, A
Plos Medicine, 4(7): 1167-1173.
ARTN e235
CrossRef
International Journal of Biochemistry & Cell Biology
Safety concerns for the potential use of cyanovirin-N as a microbicidal anti-HIV agent
Huskens, D; Vermeire, K; Vanderneulebroucke, E; Balzarini, J; Schols, D
International Journal of Biochemistry & Cell Biology, 40(): 2802-2814.
10.1016/j.biocel.2008.05.023
CrossRef
South African Journal of Science
Reducing women's risk of HIV infection: South Africa's contribution to microbicide research and development
Ramjee, G
South African Journal of Science, 96(6): 280-282.

Reproductive Health Matters
What's up with nonoxynol-9?
Forbes, A; Heise, L
Reproductive Health Matters, 8(): 156-159.

Antimicrobial Agents and Chemotherapy
3-Hydroxyphthalic Anhydride-Modified Chicken Ovalbumin Exhibits Potent and Broad Anti-HIV-1 Activity: a Potential Microbicide for Preventing Sexual Transmission of HIV-1
Li, L; He, LL; Tan, SY; Guo, XH; Lu, H; Qi, Z; Pan, CE; An, XL; Jiang, SB; Liu, SW
Antimicrobial Agents and Chemotherapy, 54(5): 1700-1711.
10.1128/AAC.01046-09
CrossRef
Nature Reviews Drug Discovery
Microbicides: A new approach to preventing HIV and other sexually transmitted infections
Stone, A
Nature Reviews Drug Discovery, 1(): 977-985.
10.1038/nrd959
CrossRef
Lancet
Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial
Van Damme, L; Ramjee, G; Alary, M; Vuylsteke, B; Chandeying, V; Rees, H; Sirivongrangson, P; Mukenge-Tshibaka, L; Ettiegne-Traore, V; Uaheowitchai, C; Karim, SSA; Masse, B; Perriens, J; Laga, M
Lancet, 360(): 971-977.

Indian Journal of Medical Research
Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India
Joshi, S; Joglekar, N; Ghate, M; Unni, J; Risbud, A; Bentley, M; Shepherd, M; Bollinger, R; Mehendale, S
Indian Journal of Medical Research, 117(): 152-157.

Journal of Virology
Genetic and neutralization properties of subtype C human immunodeficiency virus type 1 molecular env clones from acute and early heterosexually acquired infections in southern Africa
Li, M; Salazar-Gonzalez, JF; Derdeyn, CA; Morris, L; Williamson, C; Robinson, JE; Decker, JM; Li, YY; Salazar, MG; Polonis, VR; Mlisana, K; Karim, SA; Hong, KX; Greene, KM; Bilska, M; Zhou, JT; Allen, S; Chomba, E; Mulenga, J; Vwalika, C; Gao, F; Zhang, M; Korber, BTM; Hunter, E; Hahn, BH; Montefiori, DC
Journal of Virology, 80(): 11776-11790.
10.1128/JVI.01730-06
CrossRef
Antiviral Therapy
Susceptibility to genital herpes as a biomarker predictive of increased HIV risk: expansion of a murine model of microbicide safety
Wilson, SS; Cheshenko, N; Fakioglu, E; Mesquita, PMM; Keller, MJ; Herold, BC
Antiviral Therapy, 14(8): 1113-1124.
10.3851/IMP1463
CrossRef
Plos One
In Vitro and Ex Vivo Testing of Tenofovir Shows It Is Effective As an HIV-1 Microbicide
Rohan, LC; Moncla, BJ; Ayudhya, RPKN; Cost, M; Huang, Y; Gai, F; Billitto, N; Lynam, JD; Pryke, K; Graebing, P; Hopkins, N; Rooney, JF; Friend, D; Dezzutti, CS
Plos One, 5(2): -.
ARTN e9310
CrossRef
Antimicrobial Agents and Chemotherapy
Sophorolipids, microbial glycolipids with anti-human immunodeficiency virus and sperm-immobilizing activities
Shah, V; Doncel, GF; Seyoum, T; Eaton, KM; Zalenskaya, I; Hagver, R; Azim, A; Gross, R
Antimicrobial Agents and Chemotherapy, 49(): 4093-4100.
10.1128/AAC.49.10.4093-4100.2005
CrossRef
AIDS Reviews
Microbicides: a long and bumpy road to success?
Jespers, V; Laga, M; Van Herrewege, Y; Vanham, G
AIDS Reviews, 9(1): 61-62.

European Journal of Contraception and Reproductive Health Care
Update on nonoxynol-9 as vaginal spermicide
Iyer, V; Poddar, SS
European Journal of Contraception and Reproductive Health Care, 13(4): 339-350.
10.1080/13625180802263515
CrossRef
AIDS
Vaginal microbicides: moving ahead after an unexpected setback
van de Wijgert, JHHM; Shattock, RJ
AIDS, 21(): 2369-2376.

Journal of Infectious Diseases
Disruption of Tight Junctions by Cellulose Sulfate Facilitates HIV Infection: Model of Microbicide Safety
Mesquita, PMM; Cheshenko, N; Wilson, SS; Mhatre, M; Guzman, E; Fakioglu, E; Keller, MJ; Herold, BC
Journal of Infectious Diseases, 200(4): 599-608.
10.1086/600867
CrossRef
AIDS
Up-date on microbicide clinical trials for the Microbicide 2000 Conference
Roddy, RE
AIDS, 15(): S12-S13.

Journal of Infectious Diseases
The molecular basis of nonoxynol-9-induced vaginal inflammation and its possible relevance to human immunodeficiency virus type 1 transmission
Fichorova, RN; Tucker, LD; Anderson, DJ
Journal of Infectious Diseases, 184(4): 418-428.

AIDS
Nonoxynol-9 100 mg gel: multi-site safety study from sub-Saharan Africa
Hoffman, IF; Taha, TE; Padian, NS; Kelly, CW; Welch, JD; Martinson, FE; Kumwenda, NI; Rosenberg, ZF; Chilongozi, DA; Brown, JM; Chirenje, M; Richardson, BA
AIDS, 18(): 2191-2195.

Expert Opinion on Investigational Drugs
Considerations and development of topical microbicides to inhibit the sexual transmission of HIV
Turpin, JA
Expert Opinion on Investigational Drugs, 11(8): 1077-1097.

Journal of Virology
Regional clustering of shared neutralization determinants on primary isolates of clade C human immunodeficiency virus type 1 from South Africa
Bures, R; Morris, L; Williamson, C; Ramjee, G; Deers, M; Fiscus, SA; Abdool-Karim, S; Montefiori, DC
Journal of Virology, 76(5): 2233-2244.
10.1128/JVI.76.5.2233-2244.2002
CrossRef
Antimicrobial Agents and Chemotherapy
Mouse model of cervicovaginal toxicity and inflammation for preclinical evaluation of topical vaginal microbicides
Catalone, BJ; Kish-Catalone, TM; Budgeon, LR; Neely, EB; Ferguson, M; Krebs, FC; Howett, MK; Labib, M; Rando, R; Wigdahl, B
Antimicrobial Agents and Chemotherapy, 48(5): 1837-1847.
10.1128/AAC.48.5.1837-1847.2004
CrossRef
Drugs of Today
An integrated approach to the study of Chlamydia trachomatis infection of the female genital tract
Lyons, JM
Drugs of Today, 42(): 83-97.

American Journal of Obstetrics and Gynecology
Cervicovaginal colposcopic lesions associated with 5 nonoxynol-9 vaginal spermicide formulations
Harwood, B; Meyn, LA; Ballagh, SA; Raymond, EG; Archer, DF; Creinin, MD
American Journal of Obstetrics and Gynecology, 198(1): -.
ARTN 32.e1
CrossRef
Lancet
Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
Padian, NS; van der Straten, A; Ramjee, G; Chipato, T; de Bruyn, G; Blanchard, K; Shiboski, S; Montgomery, ET; Fancher, H; Cheng, H; Rosenblum, M; van der Laan, M; Jewell, N; McIntyre, J
Lancet, 370(): 251-261.

5Th European Congress on Tropical Medicine and International Health
Microbicides delivery system
Shihata, A
5Th European Congress on Tropical Medicine and International Health, (): 131-134.

Antimicrobial Agents and Chemotherapy
Candidate topical microbicides bind herpes simplex virus glycoprotein B and prevent viral entry and cell-to-cell spread
Cheshenko, N; Keller, MJ; MasCasullo, V; Jarvis, GA; Cheng, H; John, M; Li, JH; Hogarty, K; Anderson, RA; Waller, DP; Zaneveld, LJD; Profy, AT; Klotman, ME; Herold, BC
Antimicrobial Agents and Chemotherapy, 48(6): 2025-2036.
10.1128/AAC.48.6.2025-2036.2004
CrossRef
Febs Letters
SAMMA, a mandelic acid condensation polymer, inhibits dendritic cell-mediated HIV transmission
Chang, TL; Teleshova, N; Rapista, A; Palucha, M; Anderson, RA; Waller, DP; Zaneveld, LJD; Granelli-Piperno, A; Klotman, ME
Febs Letters, 581(): 4596-4602.
10.1016/j.febslet.2007.08.048
CrossRef
AIDS
Vaginal transmission of HIV-1 in hu-SCID mice: a new model for the evaluation of vaginal microbicides
Di Fabio, S; Giannini, G; Lapenta, C; Spada, M; Binelli, A; Germinario, E; Sestili, P; Belardelli, F; Proietti, E; Vella, S
AIDS, 15(): 2231-2238.

Tropical Medicine & International Health
Clinical microbicide research: an overview
Van Damme, L
Tropical Medicine & International Health, 9(): 1290-1296.

Indian Journal of Pharmaceutical Education and Research
Formulation and Modulation of Drug Release from an Intra Vaginal Ring
Iyer, V; Poddar, SS
Indian Journal of Pharmaceutical Education and Research, 43(2): 117-124.

Journal of Biomedical Optics
Automated segmentation algorithm for detection of changes in vaginal epithelial morphology using optical coherence tomography
Chitchian, S; Vincent, KL; Vargas, G; Motamedi, M
Journal of Biomedical Optics, 17(): -.
ARTN 116004
CrossRef
Plos One
Is Wetter Better? An Evaluation of Over-the-Counter Personal Lubricants for Safety and Anti-HIV-1 Activity
Dezzutti, CS; Brown, ER; Moncla, B; Russo, J; Cost, M; Wang, L; Uranker, K; Ayudhya, RPKN; Pryke, K; Pickett, J; LeBlanc, MA; Rohan, LC
Plos One, 7(): -.
ARTN e48328
CrossRef
AIDS
PRO 2000 elicits a decline in genital tract immune mediators without compromising intrinsic antimicrobial activity
Cole, AL; Cole, AM; Profy, AT; Wira, CR; Hogarty, K; Herold, BC; Keller, MJ; Guzman, E; Hazrati, E; Kasowitz, A; Cheshenko, N; Wallenstein, S
AIDS, 21(4): 467-476.
10.1097/QAD.0b013e328013d9b5
PDF (226) | CrossRef
AIDS
The safety of candidate vaginal microbicides since nonoxynol-9: a systematic review of published studies
Poynten, IM; Millwood, IY; Falster, MO; Law, MG; Andresen, DN; Van Damme, L; Kaldor, JM
AIDS, 23(10): 1245-1254.
10.1097/QAD.0b013e32832b4271
PDF (728) | CrossRef
Obstetrics & Gynecology
Effects of Long-Term Use of Nonoxynol-9 on VaginalFlora
Schreiber, CA; Meyn, LA; Creinin, MD; Barnhart, KT; Hillier, SL
Obstetrics & Gynecology, 107(1): 136-143.
10.1097/01.AOG.0000189094.21099.4a
PDF (222) | CrossRef
JAIDS Journal of Acquired Immune Deficiency Syndromes
Willingness to Use Microbicides Is Affected by the Importance of Product Characteristics, Use Parameters, and Protective Properties
Morrow, KM; Fava, JL; Rosen, RK; Vargas, S; Barroso, C; Christensen, AL; Woodsong, C; Severy, L
JAIDS Journal of Acquired Immune Deficiency Syndromes, 45(1): 93-101.
10.1097/QAI.0b013e3180415ded
PDF (179) | CrossRef
Sexually Transmitted Diseases
The Evaluation of the Local Tolerance of Vaginal Formulations, With or Without Nonoxynol-9, Using the Slug Mucosal Irritation Test
Dhondt, MM; Adriaens, E; Remon, J
Sexually Transmitted Diseases, 31(4): 229-235.

PDF (248)
AIDS
Clinical testing of microbicides: a global research priority
Karim, SS
AIDS, 15(7): 929-930.

PDF (72)
Current Opinion in Infectious Diseases
Vaginal microbicides
McCormack, S
Current Opinion in Infectious Diseases, 15(1): 57-62.

PDF (111)
Current Opinion in Infectious Diseases
Prioritizing prevention of HIV and sexually transmitted infections: first-generation vaginal microbicides
Madan, RP; Keller, MJ; Herold, BC
Current Opinion in Infectious Diseases, 19(1): 49-54.

PDF (106)
Sexually Transmitted Diseases
High Resolution Imaging of Epithelial Injury in the Sheep Cervicovaginal Tract: A Promising Model for Testing Safety of Candidate Microbicides
Vincent, KL; Bourne, N; Bell, BA; Vargas, G; Tan, A; Cowan, D; Stanberry, LR; Rosenthal, SL; Motamedi, M
Sexually Transmitted Diseases, 36(5): 312-318.
10.1097/OLQ.0b013e31819496e4
PDF (1631) | CrossRef
Sexually Transmitted Diseases
Phase I Clinical Trial of Repeat Dose Terameprocol Vaginal Ointment in Healthy Female Volunteers
Stern, J; Frazer, N; Khanna, N; Dalby, R; Connor, A; Church, A
Sexually Transmitted Diseases, 35(6): 577-582.
10.1097/OLQ.0b013e31816766af
PDF (254) | CrossRef
Sexually Transmitted Diseases
Phase I Safety Trial of Two Vaginal Microbicide Gels (Acidform or BufferGel) Used With a Diaphragm Compared to KY Jelly Used With a Diaphragm
WILLIAMS, DL; NEWMAN, DR; BALLAGH, SA; CREININ, MD; BARNHART, K; WEINER, DH; BELL, AJ; JAMIESON, DJ
Sexually Transmitted Diseases, 34(12): 977-984.
10.1097/OLQ.0b013e31813347e9
PDF (458) | CrossRef
Back to Top | Article Outline
Keywords:

microbicides; effectiveness; colposcopy; clinical trial; female sex workers; safety; HIV prevention; female controlled methods

© 2000 Lippincott Williams & Wilkins, Inc.

Login

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.