Trial of SAVVY Vaginal Gel and HIV in Nigeria
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Biosyn.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Biosyn
Collaborators:
FHI 360
United States Agency for International Development (USAID)
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00130078
First received: August 11, 2005
Last updated: September 22, 2005
Last verified: August 2005
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 11, 2005 | ||||
| Last Updated Date | September 22, 2005 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Combined incidence of HIV-1 and HIV-2 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00130078 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of SAVVY Vaginal Gel and HIV in Nigeria | ||||
| Official Title ICMJE | Randomized Controlled Trial of SAVVY and HIV in Nigeria | ||||
| Brief Summary | 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. |
||||
| Detailed Description | Heterosexual contact is now the primary route of transmission for HIV worldwide. 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Drug: 1.0% C31G SAVVY vaginal gel | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Feldblum PJ, Adeiga A, Bakare R, Wevill S, Lendvay A, Obadaki F, Olayemi MO, Wang L, Nanda K, Rountree W. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS ONE. 2008 Jan 23;3(1):e1474. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 2142 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Nigeria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00130078 | ||||
| Other Study ID Numbers ICMJE | 9784 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Biosyn | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | Biosyn | ||||
| Verification Date | August 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||