Cellulose Sulfate (CS) Gel and HIV in Nigeria

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

Nigeria

Study Type

Interventional

Intervention

Cellulose Sulfate Vaginal Gel (Microbicide)

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring 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

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Lagos University, College of Medicine, Center 10151
University of Port Harcourt Teaching Hospital, Center 10152

Outcomes

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.

Full Information

NCT ID

NCT00120770

First Posted

July 11, 2005

Last Updated

February 27, 2007

Sponsor

FHI 360

Collaborators

Lagos State University, University of Port Harcourt Teaching Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00120770

Brief Title

Cellulose Sulfate (CS) Gel and HIV in Nigeria

Official Title

Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

FHI 360

Collaborators

Lagos State University, University of Port Harcourt Teaching Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, µg microgram, ULN upper limit of the normal range, WB Western Blot, Human Immunodeficiency Virus, Neisseria gonorrhoeae, Chlamydia trachomatis, HIV Seronegativity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

2160 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cellulose Sulfate Vaginal Gel (Microbicide)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vera Halpern, MD

Organizational Affiliation

FHI 360

Official's Role

Study Director

Facility Information:

Facility Name

Lagos University, College of Medicine, Center 10151

City

Lagos

Country

Nigeria

Facility Name

University of Port Harcourt Teaching Hospital, Center 10152

City

Port Harcourt

Country

Nigeria

12. IPD Sharing Statement

Citations:

PubMed Identifier

19549331

Citation

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.

Results Reference

derived

PubMed Identifier

19023429

Citation

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.

Results Reference

derived

Links:

URL

http://www.fhi.org

Description

Related Info

URL

http://conrad.org

Description

Related Info

HIV Infections, Gonorrhea, Chlamydia Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial