Cellulose Sulfate (CS) Gel and HIV in Nigeria
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ClinicalTrials.gov Identifier: NCT00120770 |
Recruitment Status
:
Terminated
(The study was halted in January 2007 due to safety concerns.)
First Posted
: July 19, 2005
Last Update Posted
: February 28, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Gonorrhea Chlamydia Infections | Drug: Cellulose Sulfate Vaginal Gel (Microbicide) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 2160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria |
Study Start Date : | November 2004 |
Study Completion Date : | March 2007 |

- Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
- Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120770
Nigeria | |
Lagos University, College of Medicine, Center 10151 | |
Lagos, Nigeria | |
University of Port Harcourt Teaching Hospital, Center 10152 | |
Port Harcourt, Nigeria |
Study Director: | Vera Halpern, MD | FHI 360 |
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 |
First Posted: | July 19, 2005 Key Record Dates |
Last Update Posted: | February 28, 2007 |
Last Verified: | February 2007 |
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 |