- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120770
Cellulose Sulfate (CS) Gel and HIV in Nigeria
February 27, 2007 updated by: FHI 360
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
2160
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lagos, Nigeria
- Lagos University, College of Medicine, Center 10151
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Port Harcourt, Nigeria
- University of Port Harcourt Teaching Hospital, Center 10152
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
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Secondary Outcome Measures
Outcome Measure |
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Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Vera Halpern, MD, FHI 360
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Halpern 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Study Completion
March 1, 2007
Study Registration Dates
First Submitted
July 11, 2005
First Submitted That Met QC Criteria
July 18, 2005
First Posted (ESTIMATE)
July 19, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
February 28, 2007
Last Update Submitted That Met QC Criteria
February 27, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Keywords
- HIV Seronegativity
- Human Immunodeficiency Virus
- Chlamydia trachomatis
- Neisseria gonorrhoeae
- 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
- mg milligram(s)
- mm3 cubic millimeter(s)
- PCR polymerase chain reaction
- SAE serious adverse event
- µg microgram
- ULN upper limit of the normal range
- WB Western Blot
- IU international units
Additional Relevant MeSH Terms
- Pathologic Processes
- Sexually Transmitted Diseases
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Chlamydiaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Infections
- Communicable Diseases
- Chlamydia Infections
- Gonorrhea
- Anti-Infective Agents
Other Study ID Numbers
- 9757 (Fred Hutch/University of Washington Cancer Consortium)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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