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Microbicide Candidates
There are 11 microbicide products currently in clinical trials globally. Multiple candidate microbicides with different target pathogens and mechanisms of action must be tested simultaneously. This increases the probability and speed of finding a successful microbicide, and with time will lead to a variety of products with different attributes for different users.
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MICROBICIDE CANDIDATES IN ONGOING CLINICAL TRIALS SUMMARY AS OF November 2008 | ||||
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Phase |
Candidate Name |
Sponsor* |
Sites by Country | |
|
3 |
Indevus, MRC, DFID (Funder) |
South Africa, Tanzania, Uganda, Zambia | ||
|
2B |
CAPRISA, USAID, LIFElab, African Dept of Science and Technology, Gilead, FHI, CONRAD |
South Africa | ||
|
2/2B |
PRO 2000/5 gel (P) and BufferGel® |
DAIDS/NIAID, MTN, Indevus, ReProtect |
Malawi, South Africa, United States, Zambia, Zimbabwe | |
|
2 |
Tenofovir gel |
CONRAD, DAIDS/NIAID, Gilead, MTN |
South Africa, Uganda, United States | |
|
1/2 |
VivaGel® (SPL7013 gel) |
Starpharma, NIAID, NIH |
Australia | |
|
1 |
Dapivirine (TMC120) gel |
IPM |
Belgium | |
|
Ethanol in Emollient Gel |
NIAID |
Kenya | ||
|
HEC/CS/N-9† |
CONRAD/USAID |
USA | ||
|
Tenofovir gel |
CONRAD, IPM/USAID |
Dominican Republic, United States | ||
|
Tenofovir gel |
NIAID |
United States | ||
|
UC-781 gel |
NIAID, CONRAD |
United States | ||
|
UC-781 gel |
UCLA, NIAID, CONRAD |
United States | ||
|
UC-781 gel |
CDC, Thailand Ministry of Health, CONRAD |
Thailand | ||
|
UC-781 |
CONRAD |
United States | ||
|
UC-781 |
CONRAD, CDC, Emory University |
United States | ||
|
VivaGel™ (SPL7013 gel)‡ |
DAIDS/NIAID, MTN; NICHD, Starpharma |
Puerto Rico, United States | ||
| 1 | PRO 2000 | AECOM, INDEVUS, NIH | United States | |
| 1 | Tenofovir gel | CONRAD, DAIDS/NIAID; MTN; NICHD | United States | |
|
N/A |
No Product ((MTN015 - observational cohort study) | DAIDS/NIAID, MTN | Malawi, South Africa, Uganda, Zambia, Zimbabwe | |
|
N/A |
Placebo ring± |
IPM |
Kenya (follow up), South Africa, Tanzania (ongoing sites) | |
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©Alliance for Microbicide Development 2008 Definition of acronyms used in this table: Mechanism of Action (MoA), Entry/Fusion Inhibitor (EFI),Replication Inhibitor (RI), Vaginal Defense Enhancer (VDE), and Surfactant (S) *The Alliance uses the term “sponsor” as defined by the International Conference on Harmonisation (Guideline for Good Clinical Practice, 1996) as follows: “An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.”
†HEC, CS, and N-9 are not in development as microbicides. Rather, this trial’s objective is to characterize inflammation and genital epithelial changes in healthy, sexually abstinent women before, during, and after 13½ days of twice-daily applications of one of three products: a hydroxyethylcellulose (HEC)-based “universal” placebo, 6% cellulose sulfate, or 4% nonoxynol-9 (Conceptrol®) gel; to determine the degree of correlation between different methods of clinical assessment; and to determine the degree of correlation between the results of this clinical study and the results of the preclinical assessment of the same compounds. ‡ This trial has been paused pending a protocol amendment. **ATN 062, “Tell Juliana,” is an observational study taking place in parallel to MTN 004. Please visit the MRDD for further information on this ancillary study. ±This device is intended for use with a microbicide. | ||||
Candidates most advanced in Clinical Trials
The following are descriptions of the candidate microbicides entering advanced trials. For more information on these and other candidate products, please visit the Alliance for Microbicide Development’s website www.microbicide.org or check out Factsheet #13: Trials Watch in one of our different languages US English - English - French - Spanish - Russian
Please find more specifics on each of these products on the GCM's web page: Current Trials
BufferGel is an acid buffer that keeps the vagina acidic even in the presence of semen and creates a physical barrier that stops or slows down the passage of pathogens into the vaginal and cervical walls. It is expected to be contraceptive and may protect against HIV, HPV, HSV, chlamydia and gonorrhea. Carbopol 974, the major nonaqueous component of BufferGel, is commonly used as a gelling or tableting agent.
PRO 2000 (napthalene sulphonate polymer) is an entry and fusion inhibitor that binds to viruses and bacteria to prevent them from binding to and infecting healthy cells. Its contraceptive efficacy is expected to be dose dependent. It may protect against HIV, gonorrhoea and HSV.
Tenofovir is a highly specific nucleotide reverse transcriptase inhibitor (NRTI). It is an antiretroviral drug. An oral formulation of tenofovir (trade name Viread) is actively marketed by Gilead Sciences for the treatment of HIV. For potential microbicide use, tenofovir has been formulated as a 1% gel. It is likely to be highly potent, so it only takes a small amount of the active ingredient to have an effect. It is non-contraceptive and HIV specific.