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Cellulose Sulfate (CS) Gel and HIV in Nigeria

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ClinicalTrials.gov Identifier: NCT00120770
Recruitment Status : Terminated (The study was halted in January 2007 due to safety concerns.)
First Posted : July 19, 2005
Last Update Posted : February 28, 2007
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Gonorrhea Chlamydia Infections Drug: Cellulose Sulfate Vaginal Gel (Microbicide) Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria
Study Start Date : November 2004
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00120770     History of Changes
Other Study ID Numbers: 9757
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: February 28, 2007
Last Verified: February 2007

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:
Infection
Communicable Diseases
HIV Infections
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
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Anti-Infective Agents