SNPMiner Trials (Home Page)
Report for Mutation C31G
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 4 clinical trials
Clinical Trials
1 Randomized Controlled Trial of SAVVY and HIV in Ghana
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.
NCT00129532 HIV Infections Drug: 1.0% C31G SAVVY vaginal gel MeSH:HIV Infections
This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk. --- C31G ---
This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk. --- C31G ---
Primary Outcomes
Measure: combined incidence of HIV-1 and HIV-22 Randomized Controlled Trial of SAVVY and HIV in Nigeria
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.
NCT00130078 HIV Infections Drug: 1.0% C31G SAVVY vaginal gel MeSH:HIV Infections
This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk. --- C31G ---
This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk. --- C31G ---
Primary Outcomes
Measure: Combined incidence of HIV-1 and HIV-23 A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.
NCT00274261 Pregnancy Drug: C31G Drug: nonoxynol-9 (N-9)
A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®. --- C31G ---
Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol® This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. --- C31G ---
Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol® This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. --- C31G --- --- C31G ---
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.. Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.. Incidence of Adverse Events.. Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.. Inclusion Criteria: Potential subjects must: - Be healthy women, who are sexually active, at risk for pregnancy and desiring contraception. --- C31G ---
- Have previously participated in or completed this study or any other phase III study of C31G. --- C31G ---
C31G is an effective spermicide with in vitro activity equal to that of N-9 . --- C31G ---
C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. --- C31G ---
Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. --- C31G ---
Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel. --- C31G ---
Primary Outcomes
Description: Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.
Measure: The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy. Time: 6 monthsSecondary Outcomes
Description: Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.
Measure: Incidence of Adverse Events. Time: duration of the study - through 6 month or 12 months of use4 A Randomized Controlled Clinical Trial on the Effectiveness of Three Different Mouthrinses, Adjunct to Periodontal Surgery, in Dental Plaque Control and Early Wound Healing
Aim: This study compared the effectiveness of three different mouthrinses (alcohol and non-alcohol chlorhexidine, alkyl dimethyl glycine / alkyl dimethyl amine oxide - C31G) in plaque control and early wound healing, postoperatively. Materials and Methods: In this, randomized, double-blind, controlled clinical trial 42 patients were allocated to three groups assigned to two weeks rinsing after periodontal surgery with C31G (group A), alcohol-free chlorhexidine 0.12% (group B) or alcohol-based chlorhexidine 0.12% (group C). At weeks 1 and 2, plaque and early wound healing indices were recorded. At day 14, total bacterial counts were estimated utilizing real - time qPCR. Statistics included linear and generalized linear mixed models.
NCT03119831 Periodontitis Wound Healing Drug: Alcohol-based Chlorhexidine Gluconate 0.12% Drug: Alcohol-free Chlorhexidine Gluconate 0.12% Drug: C31G MeSH:Periodontitis Dental Plaque Wounds and Injuries
HPO:Periodontitis
Effectiveness of Three Different Mouthrinses in Dental Plaque Control and Early Wound Healing Aim: This study compared the effectiveness of three different mouthrinses (alcohol and non-alcohol chlorhexidine, alkyl dimethyl glycine / alkyl dimethyl amine oxide - C31G) in plaque control and early wound healing, postoperatively. --- C31G ---
Materials and Methods: In this, randomized, double-blind, controlled clinical trial 42 patients were allocated to three groups assigned to two weeks rinsing after periodontal surgery with C31G (group A), alcohol-free chlorhexidine 0.12% (group B) or alcohol-based chlorhexidine 0.12% (group C). --- C31G ---
Primary Outcomes
Description: EHI measurements range between 1-5: = Complete flap closure-no fibrin line in interproximal area. = Complete flap closure-fibrin line in interproximal area. = Complete flap closure-fibrin clot in the interproximal area. = Incomplete flap closure-partial necrosis of interproximal tissue. = Incomplete flap closure-complete necrosis of the interproximal tissue.
Measure: Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI) Time: Early Wound Healing Index was recorded at the 7th and 14th postsurgical daySecondary Outcomes
Description: PI measurements range between 0-3: 0 = No plaque = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. = Moderate accumulation of soft deposits on the tooth and gingival margin which can be seen with the naked eye. = Abundance of soft matter on the tooth and gingival margin.
Measure: Plaque Index (PI) Time: PI was recorded 14 days postoperativelyDescription: Assessment of the accumulation of dental plaque at buccal tooth surfaces between baseline (immediately before surgery), 7 and 14 days postoperatively. PA% referred at the percentage of the total buccal surface area of the included teeth covered by dental plaque. PA% values range between 0-100%
Measure: Plaque Area Index (PA%) Time: PA% was recorded at the 7th and 14th postoperative dayOther Outcomes
Description: Levels of bacterial counts, expressed in total bacterial DNA mass (ng) and total number of bacteria. TBC was evaluated by real-time Polymerase Chain Reaction (PCR).
Measure: Total Bacterial Counts (TBC) Time: Plaque samples were collected at the 14th postsurgical day.