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

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

MedlinePlus related topics:

AIDS Chlamydia Infections Gonorrhea

Drug Information available for:

Hepatitis B Vaccines Cellulose Cellulose sodium phosphate Phosphocellulose Aspartic acid Cellulose sulfate Alanine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria

Further study details as provided by Family Health International:

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

Family Health International

Lagos State University

University of Port Harcourt Teaching Hospital

Investigators


Study Director:	Vera Halpern, MD	Family Health International

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	9757
First Received:	July 11, 2005
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00120770
Health Authority:	United States: Food and Drug Administration

Keywords provided by Family Health International:

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

Study placed in the following topic categories:

Bacterial Infections

Sexually Transmitted Diseases, Viral

Acquired Immunodeficiency Syndrome

Genital Diseases, Male

N-Methylaspartate

Immunologic Deficiency Syndromes

Gram-Negative Bacterial Infections

Genital Diseases, Female

Hepatitis

Virus Diseases

HIV Infections

Chlamydia Infections

Sexually Transmitted Diseases

Hepatitis B

Gonorrhea

Retroviridae Infections

Neisseriaceae Infections

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Bacterial

Communicable Diseases

RNA Virus Infections

Chlamydiaceae Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 28, 2008

Sponsors and Collaborators:	Family Health International Lagos State University University of Port Harcourt Teaching Hospital
Information provided by:	Family Health International
ClinicalTrials.gov Identifier:	NCT00120770