Clinical trial NCT00120770: Cellulose Sulfate (CS) Gel and HIV in Nigeria
Official title: Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Lagos State University
name: University of Port Harcourt Teaching Hospital
First posted: 2005-07-19
Enrollment: 2160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
Secondary outcomes:
measure: Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Lagos University, College of Medicine, Center 10151
city: Port Harcourt
country: Nigeria
facility: University of Port Harcourt Teaching Hospital, Center 10152
Study officials:
affiliation: FHI 360
name: Vera Halpern, MD
role: STUDY_DIRECTOR
References:
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.
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.