HIV InfectionsPhase 3NCT00120770
Cellulose Sulfate (CS) Gel and HIV in Nigeria
A Phase 3 study testing Cellulose Sulfate Vaginal Gel (Microbicide) in people with HIV Infections and Gonorrhea, run by FHI 360 at 2 sites in Nigeria.
Trial summary
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection. 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, Gonorrhea, Chlamydia Infections
- What is being tested?
- Cellulose Sulfate Vaginal Gel (Microbicide)
- How many people
- 2,160 participants
- Where
- 2 sitesNigeria
- Study dates
- Nov 2004to Mar 2007
- 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
- Willing and able to give informed consent
- At least 18 years old and not more than 35 years old
- Average of three vaginal coital acts per week with a male partner
- More than one male sexual partner in the last 3 months
- Willing to use study product as directed
- Willing to adhere to follow-up schedule
Show all 11Show fewer
- Willing to participate in the study for 12 months
- Willing to report self-medication during study participation
- Willing to give urine for pregnancy testing; self-administered vaginal swabs for GC/CT testing; OMT for HIV monthly; finger prick for HIV confirmation if required; and blood draw for syphilis and HIV at baseline, and for HIV at the final visit
- Willing to not use a spermicide, other vaginal contraceptive, or vaginal lubricant during the study
- At least 3 months since end of the last pregnancy
Who cannot join
- History of adverse reactions to the study products, including latex
- Pregnant or desire a pregnancy during the 12 months of participation
- Injection drug user
- Gynecological abnormality that may have an impact on the safety and/or response to the study gel according to the investigator
- HIV positive as diagnosed by OraQuick® rapid test
- Participation in any other microbicide research
- Discontinued from the CS study previously
- Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe or complicate data interpretation
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Lagos University, College of Medicine, Center 10151
Lagos
University of Port Harcourt Teaching Hospital, Center 10152
Port Harcourt
About this study
Official title: Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
Read the detailed description
This is a Phase 3, multi-center, randomized, placebo-controlled trial to assess the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV among HIV sero-negative women at high risk for HIV infection. Eligible participants who are HIV negative, at risk for becoming infected, and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in Port Harcourt and Lagos, Nigeria. The enrollment phase will last until 2,160 women have enrolled. It is anticipated that the enrollment will be completed within 12 months.
- Conditions
- HIV Infections, Gonorrhea, Chlamydia Infections
- Being tested
- Cellulose Sulfate Vaginal Gel (Microbicide)
- Keywords
- AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU international units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range
- Medical subject headings
- HIV Infections, Gonorrhea, Chlamydia Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellulose Sulfate Vaginal Gel (Microbicide)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
Secondary outcomes (1)
Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2005 (estimated)
- Study startNov 2004
- Study completionMar 2007
Why it stopped: The study was halted in January 2007 due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 2,160 participants
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Lagos State University, University of Port Harcourt Teaching Hospital
- Investigators
- Vera Halpern, MD, Study director, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120770
- Sponsor's protocol ID
- 9757
- Status last verified
- Feb 2007
- First submitted
- 11 Jul 2005
- Last updated
- 28 Feb 2007
- Results posted
- No
Publications
Halpern V, Obunge O, Ogunsola F, Otusanya S, Umo-Otong J, Wang CH, Mehta N. Interim data monitoring to enroll higher-risk participants in HIV prevention trials. BMC Med Res Methodol. 2009 Jun 23;9:44. doi: 10.1186/1471-2288-9-44.
PubMed 19549331Halpern V, Ogunsola F, Obunge O, Wang CH, Onyejepu N, Oduyebo O, Taylor D, McNeil L, Mehta N, Umo-Otong J, Otusanya S, Crucitti T, Abdellati S. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria. PLoS One. 2008;3(11):e3784. doi: 10.1371/journal.pone.0003784. Epub 2008 Nov 21.
PubMed 19023429
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria
- ClinicalTrials.gov ID
- NCT00120770
- Acronym / sponsor ID
- 9757
- Conditions
- HIV Infections, Gonorrhea, Chlamydia Infections
- Keywords
- AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted in January 2007 due to safety concerns.
- Enrolment
- 2,160 participants
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Lagos State University, University of Port Harcourt Teaching Hospital
- Study start
- Nov 2004
- Study completion
- Mar 2007
- First posted
- 19 Jul 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.
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
Detailed description
This is a Phase 3, multi-center, randomized, placebo-controlled trial to assess the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV among HIV sero-negative women at high risk for HIV infection. Eligible participants who are HIV negative, at risk for becoming infected, and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in Port Harcourt and Lagos, Nigeria. The enrollment phase will last until 2,160 women have enrolled. It is anticipated that the enrollment will be completed within 12 months.
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 (11 listed)
- Willing and able to give informed consent
- At least 18 years old and not more than 35 years old
- Average of three vaginal coital acts per week with a male partner
- More than one male sexual partner in the last 3 months
- Willing to use study product as directed
Key exclusion criteria (8 listed)
- History of adverse reactions to the study products, including latex
- Pregnant or desire a pregnancy during the 12 months of participation
- Injection drug user
- Gynecological abnormality that may have an impact on the safety and/or response to the study gel according to the investigator
- HIV positive as diagnosed by OraQuick® rapid test
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 |
|---|---|---|
| Cellulose Sulfate Vaginal Gel (Microbicide) | Drug | – |
Primary outcome
Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
1 secondary outcome
Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.
Results and safety
The study was stopped early (reason given: The study was halted in January 2007 due to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2007.
- Derived from this study: PubMed 19549331Halpern V, Obunge O, Ogunsola F, Otusanya S, Umo-Otong J, Wang CH, Mehta N. Interim data monitoring to enroll higher-risk participants in HIV prevention trials. BMC Med Res Methodol. 2009 Jun 23;9:44. doi: 10.1186/1471-2288-9-44.
- Derived from this study: PubMed 19023429Halpern V, Ogunsola F, Obunge O, Wang CH, Onyejepu N, Oduyebo O, Taylor D, McNeil L, Mehta N, Umo-Otong J, Otusanya S, Crucitti T, Abdellati S. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria. PLoS One. 2008;3(11):e3784. doi: 10.1371/journal.pone.0003784. Epub 2008 Nov 21.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Vera Halpern, MD study director
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 Cellulose Sulfate Vaginal Gel (Microbicide) in people with HIV Infections and Gonorrhea, run by FHI 360 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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Feb 2007. 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?
The study was stopped early (reason given: The study was halted in January 2007 due to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.. 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 NCT00120770, which also lists 2 linked publications.
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 28 Feb 2007.