Cellulose Sulfate (CS) Gel and HIV in Nigeria

NCT00120770 | Terminated Phase 3

• 1 other identifier: 9757
• Study Type: interventional
• Target: 2,160
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Cellulose Sulfate Vaginal Gel (Microbicide) DRUG

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FHI 360: lead
• Lagos State University: collaborator
• University of Port Harcourt Teaching Hospital: collaborator

Study Sites (2)

Lagos University, College of Medicine, Center 10151

Lagos, Nigeria

Location

University of Port Harcourt Teaching Hospital, Center 10152

Port Harcourt, Nigeria

Location

Related Publications (2)

• 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.

  PMID: 19549331 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.

  PMID: 19023429 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

HIV Infections; Gonorrhea; Chlamydia Infections; Acquired Immunodeficiency Syndrome

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Vera Halpern, MD

  FHI 360

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2005
• First Posted: July 19, 2005
• Study Start: November 1, 2004
• Study Completion: March 1, 2007
• Last Updated: February 28, 2007

Record last verified: 2007-02

Locations

NG (2)