Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
NCT ID: NCT00705679
Last Updated: 2021-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
5029 participants
INTERVENTIONAL
2009-08-31
2012-08-31
Brief Summary
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Detailed Description
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The expected duration of participation for each participant ranges from a minimum of 12 months to a maximum of 38 months. Study participants will be randomly assigned into one of five study groups, each with a different regimen. Group 1 participants will take one TDF tablet daily and one FTC/TDF placebo tablet daily. Group 2 participants will take one TDF placebo tablet daily and one FTC/TDF tablet daily. Group 3 participants will take one TDF placebo tablet daily and one FTC/TDF placebo tablet daily. Group 4 participants will apply tenofovir 1% gel vaginally once daily. Group 5 participants will apply tenofovir 1% placebo gel vaginally once daily.
Study visits will occur every 28 days after enrollment. Medical history, a physical exam, behavioral and adherence assessment, urine and blood collection, and counseling will occur at all visits. Blood will also be collected and archived for future research at select visits. Pharmacokinetic studies will occur at some visits. A pap smear will occur at select visits. Some participants may have hair samples collected on an optional basis at study visits every 2 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo
placebo tablet
Tenofovir disoproxil fumarate
300 mg tablet
2
TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate
200 mg/300 mg tablet
Tenofovir disoproxil fumarate placebo
placebo tablet
3
TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Emtricitabine/tenofovir disoproxil fumarate placebo
placebo tablet
Tenofovir disoproxil fumarate placebo
placebo tablet
4
Application of tenofovir 1% vaginal gel once daily
Tenofovir 1% vaginal gel
1 gm/100 ml of 1% gel
5
Application of tenofovir placebo gel once daily
Tenofovir placebo
placebo gel
Interventions
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Emtricitabine/tenofovir disoproxil fumarate
200 mg/300 mg tablet
Emtricitabine/tenofovir disoproxil fumarate placebo
placebo tablet
Tenofovir disoproxil fumarate
300 mg tablet
Tenofovir disoproxil fumarate placebo
placebo tablet
Tenofovir 1% vaginal gel
1 gm/100 ml of 1% gel
Tenofovir placebo
placebo gel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
* Agree to not participate in other research studies involving drugs, medical devices, or vaginal products for duration of study.
* Agree to use effective method of contraception. More information on this criterion can be found in the protocol.
Exclusion Criteria
* Known adverse reaction to any of the study products
* Known adverse reaction to latex
* Pathologic bone fracture not related to trauma
* Non-therapeutic injection drug use in the 12 months prior to screening
* Post-exposure prophylaxis for HIV exposure within 6 months prior to enrollment
* Last pregnancy outcome 42 days or less prior to enrollment
* Gynecologic or genital procedure 42 days or less prior to enrollment
* Participation in any other research study involving drugs, medical devices, or vaginal products 30 days or less prior to enrollment
* Currently using spermicide, interferon or interleukin therapy, or certain medications. More information on this criterion can be found in the protocol.
* Any significant uncontrolled active or chronic disease. More information on this criterion can be found in the protocol.
* Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
* Intends to become pregnant in the 24 months after enrollment
* Plans to relocate or travel away from the study site for more than 8 consecutive weeks in the 24 months after enrollment
* Urinary tract infection
* Pelvic inflammatory disease, an STI, or reproductive tract infection requiring treatment
* Grade 2 or higher pelvic exam finding
* Any condition that, in the opinion of the investigator, would interfere with the study
* Pregnant or breastfeeding
18 Years
45 Years
FEMALE
Yes
Sponsors
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Microbicide Trials Network
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Zvavahera M. Chirenje, MD, FRCOG
Role: STUDY_CHAIR
UZ-UCSF Collaborative Research Programme
Jeanne Marrazzo, MD, MPH
Role: STUDY_CHAIR
University of Washington, Division of Allergy and Infectious Disease
Locations
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Wits Reproductive Health and HIV Institute CRS (WRHI CRS)
Johannesburg, Gauteng, South Africa
Soweto MTN CRS
Johannesburg, Gauteng, South Africa
Overport CRS
Asherville, KwaZulu-Natal, South Africa
Chatsworth CRS
Chatsworth, KwaZulu-Natal, South Africa
eThekwini CRS
Durban, KwaZulu-Natal, South Africa
Umkomaas CRS
eMkhomazi, KwaZulu-Natal, South Africa
Tongaat CRS
Tongaat, KwaZulu-Natal, South Africa
Verulam CRS
Verulam, KwaZulu-Natal, South Africa
Botha's Hill CRS
Westville, KwaZulu-Natal, South Africa
Isipingo CRS
Westville, KwaZulu-Natal, South Africa
CAPRISA Aurum CRS
Klerksdorp, , South Africa
MU-JHU Research Collaboration CRS
Kampala, , Uganda
Seke South CRS
Chitungwiza, , Zimbabwe
Zengeza CRS
Chitungwiza, , Zimbabwe
Spilhaus CRS
Harare, , Zimbabwe
Countries
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References
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Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3.
Rosen RK, Morrow KM, Carballo-Dieguez A, Mantell JE, Hoffman S, Gai F, Maslankowski L, El-Sadr WM, Mayer KH. Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study. J Womens Health (Larchmt). 2008 Apr;17(3):383-92. doi: 10.1089/jwh.2006.0325.
Chirenje ZM, Gundacker HM, Richardson B, Rabe L, Gaffoor Z, Nair GL, Mirembe BG, Piper JM, Hillier S, Marrazzo J. Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003). Sex Transm Dis. 2017 Mar;44(3):135-140. doi: 10.1097/OLQ.0000000000000568.
Moodley J, Naidoo S, Moodley J, Ramjee G. Sharing of Investigational Drug Among Participants in the Voice Trial. AIDS Behav. 2016 Nov;20(11):2709-2714. doi: 10.1007/s10461-016-1414-x.
van der Straten A, Brown ER, Marrazzo JM, Chirenje MZ, Liu K, Gomez K, Marzinke MA, Piper JM, Hendrix CW; MTN-003 VOICE Protocol Team for Microbicide Trials Network. Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc. 2016 Feb 4;19(1):20642. doi: 10.7448/IAS.19.1.20642. eCollection 2016.
Noguchi LM, Richardson BA, Baeten JM, Hillier SL, Balkus JE, Chirenje ZM, Bunge K, Ramjee G, Nair G, Palanee-Phillips T, Selepe P, van der Straten A, Parikh UM, Gomez K, Piper JM, Watts DH, Marrazzo JM; VOICE Study Team. Risk of HIV-1 acquisition among women who use diff erent types of injectable progestin contraception in South Africa: a prospective cohort study. Lancet HIV. 2015 Jul;2(7):e279-87. doi: 10.1016/S2352-3018(15)00058-2.
Dai JY, Hendrix CW, Richardson BA, Kelly C, Marzinke M, Chirenje ZM, Marrazzo JM, Brown ER. Pharmacological Measures of Treatment Adherence and Risk of HIV Infection in the VOICE Study. J Infect Dis. 2016 Feb 1;213(3):335-42. doi: 10.1093/infdis/jiv333. Epub 2015 Jun 29.
Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van der Straten A, Noguchi L, Hendrix CW, Dai JY, Ganesh S, Mkhize B, Taljaard M, Parikh UM, Piper J, Masse B, Grossman C, Rooney J, Schwartz JL, Watts H, Marzinke MA, Hillier SL, McGowan IM, Chirenje ZM; VOICE Study Team. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015 Feb 5;372(6):509-18. doi: 10.1056/NEJMoa1402269.
Other Identifiers
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10622
Identifier Type: REGISTRY
Identifier Source: secondary_id
MTN-003
Identifier Type: OTHER
Identifier Source: secondary_id
VOICE
Identifier Type: OTHER
Identifier Source: secondary_id
MTN-003 (VOICE)
Identifier Type: -
Identifier Source: org_study_id