Chlamydia Infections, Gonorrhea, HIV Infections
Conditions
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
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.
Interventions
DRUGCellulose Sulfate Vaginal Gel (Microbicide)
Sponsors
Lagos State University
University of Port Harcourt Teaching Hospital
FHI 360
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs. | — |
Countries
Nigeria
Outcome results
None listed