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Sponsored by: |
Family Health International |
---|---|
Information provided by: | Family Health International |
ClinicalTrials.gov Identifier: | NCT00625404 |
This Phase III, double-blind, randomized, placebo-controlled trial will enroll an estimated 3900 HIV-negative women from 6 sites in 4 countries (Kenya, Malawi, Tanzania and South Africa). The study's purpose is to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through sexual intercourse.
The study population includes HIV-antibody-negative women between the ages of 18-35 who are at risk of HIV acquisition through sexual intercourse. Each participant will be randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo. All participants will receive risk reduction counseling and condoms. Women must be using a study-approved effective non-barrier contraceptive method at the time of enrollment and will be asked to do so for the whole period they are on study drug. They will receive contraceptive counseling throughout the study. Any diagnosed, treatable sexually transmitted infection will be treated free of charge.
Study duration is approximately 37-40 months at each site; participant screening and enrollment is anticipated to take approximately 12-16 months. After enrollment, each participant will be followed every four weeks for 52 weeks on study drug. All participants will be followed for an additional four weeks after study drug has been stopped. Participants at risk for hepatitis B virus (HBV) flare will be followed every four weeks for at least 12 weeks after stopping study product. Participants who acquire HIV infection during the study will stop taking the study drug at the time of HIV diagnosis, will be followed for 52 weeks post diagnosis and will be referred for care and treatment. Participants who become pregnant will stop taking the study drug but will continue follow-up visits. After the study, incidence rates of HIV infection will be compared between the two groups (active drug and placebo) using the intent-to-treat principle.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Truvada® Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women |
Estimated Enrollment: | 3900 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Truvada® Participants in both study arms will receive risk reduction counseling and condoms. |
Drug: Truvada®
Truvada® is made by Gilead Sciences, Inc. Truvada® tablets are blue capsule-shaped film-coated tablets containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Dosage for this study is one tablet per day, taken orally as close as possible to twenty-four hours apart. Participants in both study arms will receive risk reduction counseling and condoms. |
2: Placebo Comparator
Placebo tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients. Placebo tablets contain the same inactive ingredients as Truvada (croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch), plus denatonium benzoate to provide a bitter taste to match the active tablets. Participants in both study arms will receive risk reduction counseling and condoms. |
Drug: Placebo
Placebo tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients. Placebo tablets contain the same inactive ingredients as Truvada (croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch), plus denatonium benzoate to provide a bitter taste to match the active tablets. Participants in both study arms will receive risk reduction counseling and condoms. |
This Phase III, double-blind, randomized, placebo-controlled trial will enroll an estimated 3900 HIV-negative women from 6 sites in 4 countries (Kenya, Malawi, Tanzania and South Africa). The study's purpose is to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through sexual intercourse.
The study population includes HIV-antibody-negative women between the ages of 18-35 who are at risk of HIV acquisition through sexual intercourse. Each participant will be randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo. All participants will receive risk reduction counseling and condoms. Women must be using a study-approved effective non-barrier contraceptive method at the time of enrollment and will be asked to do so for the whole period they are on study drug. They will receive contraceptive counseling throughout the study. Any diagnosed, treatable sexually transmitted infection will be treated free of charge.
Study duration is approximately 37-40 months at each site; participant screening and enrollment is anticipated to take approximately 12-16 months. After enrollment, each participant will be followed every four weeks for 52 weeks on study drug. All participants will be followed for an additional four weeks after study drug has been stopped. Participants at risk for Hepatitis B Virus (HBV) flare will be followed every four weeks for at least 12 weeks after stopping study product. Participants who acquire HIV infection during the study will stop taking the study drug at the time of HIV diagnosis, and will be followed for 52 weeks post diagnosis and will be referred for care and treatment. Participants who become pregnant will stop taking the study drug but will continue follow-up visits. After the study, incidence rates of HIV infection will be compared between the two groups (active drug and placebo) using the intent-to-treat principle.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Willing to participate in all aspects of the study and to comply with study procedures, for up to 56 weeks, including:
Medically eligible at screening including:
Contact: Lut Van Damme, MD, MS, PhD | (703) 516-9779 | lvandamme@fhi.org |
Kenya, Nyanza | |
Bondo Clinic, Bondo District Hospital | |
Bondo, Nyanza, Kenya | |
Malawi, Central Region | |
Research, Training & Care Center - Kamuzu Central Hospital | |
Lilongwe, Central Region, Malawi | |
Malawi, Southern Region | |
University of Malawi College of Medicine - Johns Hopkins University | |
Blantyre, Southern Region, Malawi | |
South Africa, Gauteng | |
Setshaba Research Centre | |
Pretoria, Gauteng, South Africa | |
South Africa, Western Cape | |
University of Cape Town | |
Cape Town, Western Cape, South Africa | |
Tanzania | |
Arusha Clinic, Levolosi Health Center | |
Arusha, Tanzania |
Principal Investigator: | Lut Van Damme, MD, MS, PhD | Family Health International |
Principal Investigator: | Amy Corneli, PhD, MPH, CHES | Family Health International |
Study Director: | Jennifer Deese, MPH | Family Health International |
Responsible Party: | Family Health International ( Dr. Lut Van Damme ) |
Study ID Numbers: | 10015 |
Study First Received: | February 19, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00625404 |
Health Authority: | United States: Food and Drug Administration; Belgium: Institutional Review Board; Tanzania: National Institute for Medical Research; Tanzania: Food & Drug Administration; Malawi: National Health Sciences Research Committee; South Africa: National Health Research Ethics Council; South Africa: National Health Research Ethics Council; South Africa: Medicines Control Council; Kenya: Ethical Review Committee; Kenya: Ministry of Health; Kenya: Institutional Review Board |
HIV HIV Prevention Oral PrEP Truvada women Tenofovir |
TDF FTC emtricitabine hepatitis HIV Seronegativity |
Virus Diseases Hepatitis Sexually Transmitted Diseases, Viral Emtricitabine Benzoates HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |