Cellulose Sulfate (CS) Gel and HIV in Nigeria | NCT00120770

Studies
Cellulose Sulfate (CS) Gel and HIV in Nigeria

NCT00120770

Sponsor

FHI 360

Status

Terminated

Last Update Posted

Feb 28, 2007Estimated

Enrollment

2,160

Phase

Phase 3

Conditions

HIV Infections
Gonorrhea
Chlamydia Infections

Interventions

Cellulose Sulfate Vaginal Gel (Microbicide)

Countries

Nigeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was halted in January 2007 due to safety concerns.

Expanded Access Info

Not provided

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Mar 2007

First Submitted Date

Jul 11, 2005

First Submission Date that Met QC Criteria

Jul 18, 2005

First Posted Date

Jul 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2007

Last Update Posted Date

Feb 28, 2007Estimated

Name	Class
Lagos State University	OTHER
University of Port Harcourt Teaching Hospital	OTHER

Description Module

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.

Conditions Module

Conditions

HIV Infections
Gonorrhea
Chlamydia Infections

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,160

Name	Type	Description	Arm Group Labels	Other Names
Cellulose Sulfate Vaginal Gel (Microbicide)	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Vera Halpern, MD	FHI 360	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Lagos University, College of Medicine, Center 10151		Lagos			Nigeria
University of Port Harcourt Teaching Hospital, Center 10152

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19549331	Derived	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. doi: 10.1186/1471-2288-9-44.
19023429	Derived	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. doi: 10.1371/journal.pone.0003784. Epub 2008 Nov 21.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

ID	Term
D015658	HIV Infections
D006069	Gonorrhea
D002690	Chlamydia Infections
D000163	Acquired Immunodeficiency Syndrome