Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Family Health International Lagos State University University of Port Harcourt Teaching Hospital |
---|---|
Information provided by: | Family Health International |
ClinicalTrials.gov Identifier: | NCT00120770 |
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 | Intervention | Phase |
---|---|---|
HIV Infections Gonorrhea Chlamydia Infections |
Drug: Cellulose Sulfate Vaginal Gel (Microbicide) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria |
Estimated Enrollment: | 2160 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Nigeria | |
Lagos University, College of Medicine, Center 10151 | |
Lagos, Nigeria | |
University of Port Harcourt Teaching Hospital, Center 10152 | |
Port Harcourt, Nigeria |
Study Director: | Vera Halpern, MD | Family Health International |
Study ID Numbers: | 9757 |
Study First Received: | July 11, 2005 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00120770 |
Health Authority: | United States: Food and Drug Administration |
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 |
Bacterial Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Genital Diseases, Male N-Methylaspartate Immunologic Deficiency Syndromes Gram-Negative Bacterial Infections Genital Diseases, Female Hepatitis |
Virus Diseases HIV Infections Chlamydia Infections Sexually Transmitted Diseases Hepatitis B Gonorrhea Retroviridae Infections Neisseriaceae Infections |
Sexually Transmitted Diseases, Bacterial Communicable Diseases RNA Virus Infections Chlamydiaceae Infections |
Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |