HIV InfectionsPhase 3NCT00130078
Trial of SAVVY Vaginal Gel and HIV in Nigeria
A Phase 3 study testing 1.0% C31G SAVVY vaginal gel in people with HIV Infections, run by Biosyn at 2 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- 1.0% C31G SAVVY vaginal gel
- How many people
- 2,142 participants
- Where
- 2 sitesNigeria
- Study dates
- Sep 2004to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 35 year old women
- HIV negative
- More than one sexual partner in past 3 months
- Average 3 coital acts per week
- Willing to use vaginal gel and condoms for 12 months
Who cannot join
- HIV positive
- Pregnant
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites, 2 recruiting
- Recruiting
Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan
Ibadan
Rasheed A Bakare, MBBS,FWACP
Rasheed A Bakare, MBBS,FWACP
- Recruiting
Nigerian Institute of Medical Research
Lagos
Adesina Adeiga, DVM, MSc
Adesina Adeiga, DVM, MSc
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- 1.0% C31G SAVVY vaginal gel
- Keywords
- HIV Seronegativity, HIV transmission
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.0% C31G SAVVY vaginal gelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of HIV-1 and HIV-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,142 participants
Sponsor and investigators
- Lead sponsor
- Biosyn
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FHI 360, United States Agency for International Development (USAID)
- Investigators
- Paul Feldblum, Study chair, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130078
- Sponsor's protocol ID
- 9784
- Status last verified
- Aug 2005
- First submitted
- 11 Aug 2005
- Last updated
- 26 Sep 2005
- Results posted
- No
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. doi: 10.1371/journal.pone.0001474.
PubMed 18213382
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of SAVVY and HIV in Nigeria
- ClinicalTrials.gov ID
- NCT00130078
- Acronym / sponsor ID
- 9784
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV transmission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,142 participants
- Lead sponsor
- BiosynIndustry (pharma, biotech, devices)
- Collaborators
- FHI 360, United States Agency for International Development (USAID)
- Study start
- Sep 2004
- First posted
- 15 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 35 year old women
- HIV negative
- More than one sexual partner in past 3 months
- Average 3 coital acts per week
- Willing to use vaginal gel and condoms for 12 months
Key exclusion criteria (2 listed)
- HIV positive
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.0% C31G SAVVY vaginal gel | Drug | – |
Primary outcome
Combined incidence of HIV-1 and HIV-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2005.
- Derived from this study: PubMed 18213382Feldblum 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. doi: 10.1371/journal.pone.0001474.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Feldblum study chair
FHI 360
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1.0% C31G SAVVY vaginal gel in people with HIV Infections, run by Biosyn at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Feldblum (919 544-7040 ext. 237, pfeldblum@fhi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined incidence of HIV-1 and HIV-2. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00130078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2005.