Cellulose Sulfate (CS) Gel and HIV in Nigeria
This study has been terminated.
(The study was halted in January 2007 due to safety concerns.)
Sponsor:
FHI 360
Collaborators:
Lagos State University
University of Port Harcourt Teaching Hospital
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT00120770
First received: July 11, 2005
Last updated: February 27, 2007
Last verified: February 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Gonorrhea Chlamydia Infections |
Drug: Cellulose Sulfate Vaginal Gel (Microbicide) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria |
Resource links provided by NLM:
Further study details as provided by FHI 360:
Primary Outcome Measures:
- Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
Secondary Outcome Measures:
- Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.
| Estimated Enrollment: | 2160 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | March 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120770
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120770
Locations
| Nigeria | |
| Lagos University, College of Medicine, Center 10151 | |
| Lagos, Nigeria | |
| University of Port Harcourt Teaching Hospital, Center 10152 | |
| Port Harcourt, Nigeria | |
Sponsors and Collaborators
FHI 360
Lagos State University
University of Port Harcourt Teaching Hospital
Investigators
| Study Director: | Vera Halpern, MD | FHI 360 |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00120770 History of Changes |
| Other Study ID Numbers: | 9757 |
| Study First Received: | July 11, 2005 |
| Last Updated: | February 27, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by FHI 360:
|
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 WB Western Blot Human Immunodeficiency Virus Neisseria gonorrhoeae Chlamydia trachomatis HIV Seronegativity |
Additional relevant MeSH terms:
|
Infection Communicable Diseases HIV Infections Chlamydia Infections Gonorrhea Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial Genital Diseases, Male Genital Diseases, Female Neisseriaceae Infections Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 26, 2016