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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 11, 2005

Last Updated Date

February 27, 2007

Start Date ^†

November 2004

Current Primary Outcome Measures ^†

Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00120770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Cellulose Sulfate (CS) Gel and HIV in Nigeria

Official Title ^†

Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria

Brief Summary

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.

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

HIV Infections
Gonorrhea
Chlamydia Infections

Intervention ^†

Drug: Cellulose Sulfate Vaginal Gel (Microbicide)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

2160

Completion Date

March 2007

Primary Completion Date

Eligibility 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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Nigeria

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00120770

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Family Health International

Collaborators ^††

Lagos State University
University of Port Harcourt Teaching Hospital

Investigators ^†

Study Director:

Vera Halpern, MD

Family Health International

Information Provided By

Family Health International

Verification Date

February 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.