HIV InfectionsPhase 2NCT00705679

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

A Phase 2 study testing Emtricitabine/tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate and Tenofovir 1% vaginal gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Emtricitabine/tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate and Tenofovir 1% vaginal gel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5,029 participants
Where: 15 sitesin 3 countries
Study dates: Aug 2009to Aug 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 19Show fewer

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

Trial locations and contacts

15 sites in 3 countries.

Country

City, postcode or hospital

15 sites in 3 countries

South Africa11 sites

Overport CRS
Asherville, KwaZulu-Natal, 4091
Chatsworth CRS
Chatsworth, KwaZulu-Natal, 4030
eThekwini CRS
Durban, KwaZulu-Natal, 4001
Umkomaas CRS
eMkhomazi, KwaZulu-Natal, 4170
Wits Reproductive Health and HIV Institute CRS (WRHI CRS)
Johannesburg, Gauteng, 2001
Soweto MTN CRS
Johannesburg, Gauteng
CAPRISA Aurum CRS
Klerksdorp, 2571
Tongaat CRS
Tongaat, KwaZulu-Natal, 4400
Verulam CRS
Verulam, KwaZulu-Natal, 4340
Botha's Hill CRS
Westville, KwaZulu-Natal, 3630
Isipingo CRS
Westville, KwaZulu-Natal, 3630

Other trials in South Africa

Zimbabwe3 sites

Seke South CRS
Chitungwiza
Zengeza CRS
Chitungwiza
Spilhaus CRS
Harare

Other trials in Zimbabwe

Uganda1 site

MU-JHU Research Collaboration CRS
Kampala

Other trials in Uganda

About this study

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

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.

Read the 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.

Conditions: HIV Infections
Being tested: Emtricitabine/tenofovir disoproxil fumarate, Emtricitabine/tenofovir disoproxil fumarate placebo, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate placebo, Tenofovir 1% vaginal gel
Keywords: Microbicide, HIV Seronegativity
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Emtricitabine/tenofovir disoproxil fumarateDrug
Also called FTC/TDF, Truvada
200 mg/300 mg tablet
Emtricitabine/tenofovir disoproxil fumarate placeboDrug
Also called FTC/TDF placebo, Truvada placebo
placebo tablet
Tenofovir disoproxil fumarateDrug
Also called TDF
300 mg tablet
Tenofovir disoproxil fumarate placeboDrug
Also called TDF placebo
placebo tablet
Tenofovir 1% vaginal gelDrug
Also called TFV, 9-[2-(Phosphonomethoxy)propyl]adenine
1 gm/100 ml of 1% gel
Tenofovir placeboDrug
Also called TFV placebo
placebo gel

Study groups in NCT00705679
Study group	Role	What they receive
1	Experimental	TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate placebo; Drug: Tenofovir disoproxil fumarate
2	Experimental	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 Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Tenofovir disoproxil fumarate placebo
3	Experimental	TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate placebo; Drug: Tenofovir disoproxil fumarate placebo
4	Experimental	Application of tenofovir 1% vaginal gel once daily Receives: Drug: Tenofovir 1% vaginal gel
5	Experimental	Application of tenofovir placebo gel once daily Receives: Drug: Tenofovir placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: For up to 30 months of 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).
Measured: For up to 30 months of follow-up
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).
Measured: For up to 30 months of follow-up
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.
Measured: For up to 30 months of follow-up
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).
Measured: For up to 30 months of follow-up
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).
Measured: For up to 30 months of follow-up
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.
Measured: For up to 30 months of 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).
Measured: For up to 30 months of follow-up
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).
Measured: For up to 30 months of follow-up
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.
Measured: Throughout study, up to 2.5 years

Secondary outcomes (1)

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.
Measured: Throughout study, up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Aug 2012

First posted26 Jun 2008 (estimated)
Study startAug 2009
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5,029 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00705679
Sponsor's protocol ID: MTN-003 (VOICE)
Other IDs: 10622, MTN-003, 5U01AI068633-05, VOICE
Status last verified: Feb 2016
First submitted: 24 Jun 2008
Last updated: 29 Oct 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 16470118
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.
PubMed 18328009
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.
PubMed 28178109
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.
PubMed 27146827
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.
PubMed 26850270
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.
PubMed 26155597
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.
PubMed 26123563
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.
PubMed 25651245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00705679
Acronym / sponsor ID: MTN-003 (VOICE)
Conditions: HIV Infections
Keywords: Microbicide, HIV Seronegativity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,029 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Microbicide Trials Network
Study start: Aug 2009
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 26 Jun 2008 (estimated)
Results: Posted 10 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
1	Experimental	Drug: Emtricitabine/tenofovir disoproxil fumarate placebo, Drug: Tenofovir disoproxil fumarateTDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
2	Experimental	Drug: Emtricitabine/tenofovir disoproxil fumarate, Drug: Tenofovir disoproxil fumarate placeboTDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months
3	Experimental	Drug: Emtricitabine/tenofovir disoproxil fumarate placebo, Drug: Tenofovir disoproxil fumarate placeboTDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months
4	Experimental	Drug: Tenofovir 1% vaginal gelApplication of tenofovir 1% vaginal gel once daily
5	Experimental	Drug: Tenofovir placeboApplication of tenofovir placebo gel once daily

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Emtricitabine/tenofovir disoproxil fumarateAlso: FTC/TDF, Truvada200 mg/300 mg tablet	Drug	2
Emtricitabine/tenofovir disoproxil fumarate placeboAlso: FTC/TDF placebo, Truvada placeboplacebo tablet	Drug	1, 3
Tenofovir disoproxil fumarateAlso: TDF300 mg tablet	Drug	1
Tenofovir disoproxil fumarate placeboAlso: TDF placeboplacebo tablet	Drug	2, 3
Tenofovir 1% vaginal gelAlso: TFV, 9-[2-(Phosphonomethoxy)propyl]adenine1 gm/100 ml of 1% gel	Drug	4
Tenofovir placeboAlso: TFV placeboplacebo gel	Drug	5

Primary outcome

Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: For up to 30 months of follow-up
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
Time frame: Throughout study, up to 2.5 years
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.

1 secondary outcome

Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product
Time frame: Throughout study, up to 2.5 years

Results and safety

Results posted to the registry on 10 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral TDF	1,007	942
Oral TDF-FTC	1,003	864
Oral Placebo	1,009	894
TFV Gel	1,007	927
Gel Placebo	1,003	934

Primary outcome: Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms

Time frame: For up to 30 months of follow-up. Number. Unit: person-years

Measure	TFV Gel n = 996	Placebo Gel n = 996
Value	1024	1030

Population analysed: All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.

Primary outcome: Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms

Time frame: For up to 30 months of follow-up. Number. Unit: participants

Measure	TFV Gel n = 996	Placebo Gel n = 996
Value	61	70

Primary outcome: Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms

Time frame: For up to 30 months of follow-up. Number (95% Confidence Interval). Unit: cases per 100 person-years

Measure	TFV Gel n = 996	Placebo Gel n = 996
Value	6.0 (4.6 to 7.6)	6.8 (5.3 to 8.6)

TFV Gel vs Placebo Gel: Hazard Ratio (HR): 0.85 (95% CI 0.61 to 1.21), p = 0.37, Regression, Cox

Primary outcome: Person-years of Follow-up of Oral TDF and Oral Placebo Arms

Time frame: For up to 30 months of follow-up. Number. Unit: person-years

Measure	Oral TDF n = 993	Oral Placebo n = 999
Value	823	838

1 secondary outcome is reported in the full results.

Adverse events

Time frame: each participant followed on study up to 2 years, 6 months. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral TDF	17 of 1,007 (1.7%)	646 of 1,007 (64.2%)	Not reported
Oral TDF-FTC	42 of 1,003 (4.2%)	740 of 1,003 (73.8%)	Not reported
Oral Placebo	57 of 1,009 (5.6%)	747 of 1,009 (74%)	Not reported
TFV Gel	39 of 1,007 (3.9%)	705 of 1,007 (70%)	Not reported
Gel Placebo	26 of 1,003 (2.6%)	715 of 1,003 (71.3%)	Not reported

Limitations and caveats (from the sponsor): In September 2011, the oral TDF arm was discontinued for futility; in November 2011, the TFV gel and gel placebo arms were discontinued for futility. The TDF-FTC and oral placebo arms continued follow-up until the end of study in August 2012.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16470118Mayer 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.
Background: PubMed 18328009Rosen 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.
Derived from this study: PubMed 28178109Chirenje 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.
Derived from this study: PubMed 27146827Moodley 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.
Derived from this study: PubMed 26850270van 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.
Derived from this study: PubMed 26155597Noguchi 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.
Derived from this study: PubMed 26123563Dai 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.
Derived from this study: PubMed 25651245Marrazzo 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.
Click here for the Microbicide Trials Network Web siteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zvavahera M. Chirenje, MD, FRCOG study chair

UZ-UCSF Collaborative Research Programme

Jeanne Marrazzo, MD, MPH study chair

University of Washington, Division of Allergy and Infectious Disease

15 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in South Africa, Zimbabwe, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms (time frame: For up to 30 months of follow-up). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00705679, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.