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Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate placebo
Tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate placebo
Tenofovir 1% vaginal gel
Tenofovir placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Microbicide, HIV Seronegativity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Willing to provide adequate locator information
  • 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:

  • HIV infected
  • 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

Sites / Locations

  • Wits Reproductive Health and HIV Institute CRS (WRHI CRS)
  • Soweto MTN CRS
  • Overport CRS
  • Chatsworth CRS
  • eThekwini CRS
  • Tongaat CRS
  • Umkomaas CRS
  • Verulam CRS
  • Botha's Hill CRS
  • Isipingo CRS
  • CAPRISA Aurum CRS
  • MU-JHU Research Collaboration CRS
  • Seke South CRS
  • Zengeza CRS
  • Spilhaus CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

Arm Description

TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months

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

TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months

Application of tenofovir 1% vaginal gel once daily

Application of tenofovir placebo gel once daily

Outcomes

Primary Outcome Measures

Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.
Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).
Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).
Person-years of Follow-up of Oral TDF and Oral Placebo Arms
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.
Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).
Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).
Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.
Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).
Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).
Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events
This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.

Secondary Outcome Measures

Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product
The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.

Full Information

First Posted
June 24, 2008
Last Updated
October 15, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Microbicide Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT00705679
Brief Title
Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
Official Title
Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Microbicide Trials Network

4. Oversight

5. Study Description

Brief Summary
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.
Detailed Description
It is necessary to monitor both the adherence and blood levels of microbicides in order to gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir gel) and anti-HIV drugs (TDF, FTC/TDF), this study will measure the effectiveness and safety to and blood levels of the three interventions in three regimens given to HIV uninfected women. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Microbicide, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5029 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Arm Title
2
Arm Type
Experimental
Arm Description
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
Arm Title
3
Arm Type
Experimental
Arm Description
TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
Arm Title
4
Arm Type
Experimental
Arm Description
Application of tenofovir 1% vaginal gel once daily
Arm Title
5
Arm Type
Experimental
Arm Description
Application of tenofovir placebo gel once daily
Intervention Type
Drug
Intervention Name(s)
Emtricitabine/tenofovir disoproxil fumarate
Other Intervention Name(s)
FTC/TDF, Truvada
Intervention Description
200 mg/300 mg tablet
Intervention Type
Drug
Intervention Name(s)
Emtricitabine/tenofovir disoproxil fumarate placebo
Other Intervention Name(s)
FTC/TDF placebo, Truvada placebo
Intervention Description
placebo tablet
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate
Other Intervention Name(s)
TDF
Intervention Description
300 mg tablet
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate placebo
Other Intervention Name(s)
TDF placebo
Intervention Description
placebo tablet
Intervention Type
Drug
Intervention Name(s)
Tenofovir 1% vaginal gel
Other Intervention Name(s)
TFV, 9-[2-(Phosphonomethoxy)propyl]adenine
Intervention Description
1 gm/100 ml of 1% gel
Intervention Type
Drug
Intervention Name(s)
Tenofovir placebo
Other Intervention Name(s)
TFV placebo
Intervention Description
placebo gel
Primary Outcome Measure Information:
Title
Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Description
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.
Time Frame
For up to 30 months of follow-up
Title
Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Description
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).
Time Frame
For up to 30 months of follow-up
Title
Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Description
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).
Time Frame
For up to 30 months of follow-up
Title
Person-years of Follow-up of Oral TDF and Oral Placebo Arms
Description
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.
Time Frame
For up to 30 months of follow-up
Title
Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms
Description
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).
Time Frame
For up to 30 months of follow-up
Title
Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms
Description
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).
Time Frame
For up to 30 months of follow-up
Title
Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms
Description
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.
Time Frame
For up to 30 months of follow-up
Title
Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
Description
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).
Time Frame
For up to 30 months of follow-up
Title
Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
Description
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).
Time Frame
For up to 30 months of follow-up
Title
Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events
Description
This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.
Time Frame
Throughout study, up to 2.5 years
Secondary Outcome Measure Information:
Title
Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product
Description
The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.
Time Frame
Throughout study, up to 2.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Willing to provide adequate locator information 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: HIV infected 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zvavahera M. Chirenje, MD, FRCOG
Organizational Affiliation
UZ-UCSF Collaborative Research Programme
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeanne Marrazzo, MD, MPH
Organizational Affiliation
University of Washington, Division of Allergy and Infectious Disease
Official's Role
Study Chair
Facility Information:
Facility Name
Wits Reproductive Health and HIV Institute CRS (WRHI CRS)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Soweto MTN CRS
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Overport CRS
City
Asherville
State/Province
KwaZulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Chatsworth CRS
City
Chatsworth
State/Province
KwaZulu-Natal
ZIP/Postal Code
4030
Country
South Africa
Facility Name
eThekwini CRS
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Tongaat CRS
City
Tongaat
State/Province
KwaZulu-Natal
ZIP/Postal Code
4400
Country
South Africa
Facility Name
Umkomaas CRS
City
Umkomaas
State/Province
KwaZulu-Natal
ZIP/Postal Code
4170
Country
South Africa
Facility Name
Verulam CRS
City
Verulam
State/Province
KwaZulu-Natal
ZIP/Postal Code
4340
Country
South Africa
Facility Name
Botha's Hill CRS
City
Westville
State/Province
KwaZulu-Natal
ZIP/Postal Code
3630
Country
South Africa
Facility Name
Isipingo CRS
City
Westville
State/Province
KwaZulu-Natal
ZIP/Postal Code
3630
Country
South Africa
Facility Name
CAPRISA Aurum CRS
City
Klerksdorp
ZIP/Postal Code
2571
Country
South Africa
Facility Name
MU-JHU Research Collaboration CRS
City
Kampala
Country
Uganda
Facility Name
Seke South CRS
City
Chitungwiza
Country
Zimbabwe
Facility Name
Zengeza CRS
City
Chitungwiza
Country
Zimbabwe
Facility Name
Spilhaus CRS
City
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Citations:
PubMed Identifier
16470118
Citation
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.
Results Reference
background
PubMed Identifier
18328009
Citation
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.
Results Reference
background
PubMed Identifier
28178109
Citation
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.
Results Reference
derived
PubMed Identifier
27146827
Citation
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. Erratum In: AIDS Behav. 2016 Nov;20(11):2715-2716.
Results Reference
derived
PubMed Identifier
26850270
Citation
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.
Results Reference
derived
PubMed Identifier
26155597
Citation
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.
Results Reference
derived
PubMed Identifier
26123563
Citation
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.
Results Reference
derived
PubMed Identifier
25651245
Citation
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.
Results Reference
derived
Links:
URL
http://www.mtnstopshiv.org/
Description
Click here for the Microbicide Trials Network Web site

Learn more about this trial

Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

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