Cellulose Sulfate (CS) Gel and HIV in Nigeria - Full Text View

Sponsor:	FHI 360
Collaborators:	Lagos State University University of Port Harcourt Teaching Hospital
Information provided by:	FHI 360
ClinicalTrials.gov Identifier:	NCT00120770

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 III

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Chlamydia Infections Gonorrhea HIV/AIDS

Drug Information available for: Cellulose sodium phosphate Cellulose Phosphocellulose Cellulose sulfate

U.S. FDA Resources

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by FHI 360

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Epub 2008 Nov 21.

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:

HIV Infections
Acquired Immunodeficiency Syndrome
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

Slow Virus Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012