CompletedNCT00557245Partners PrEPUpdated Apr 19, 2019Results posted

Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

A Phase 3 interventional study of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infections and HIV Infections, sponsored by University of Washington. Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by University of Washington · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 4,758
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.

Read the detailed description

HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable, HIV-1 discordant couples.

Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention strategy.

This study was a randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples. The HIV-1 uninfected partner was randomized in a 1:1:1 ratio to one of three arms: once daily Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) or Placebo.

Couples were followed up to 36 months; the HIV uninfected partner attended monthly visits and the HIV infected partner quarterly visits. All participants received a comprehensive package of HIV prevention services including individual and couples counseling, free condoms, and male circumcision referrals.

Participants who seroconverted during follow-up stopped the study drug but continued with follow-up.

Conditions studied

HIV-1 Infections
HIV Infections

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Keywords

HIV infection
HIV uninfected partners
Double Blind
Placebo
Seroconversion
TDF
FTC TDF
Safety
HIV Seronegativity

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 4,758 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria for HIV-1 uninfected partner:

Partner within an HIV-1 discordant heterosexual relationship
One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
Plan to remain in the relationship for the duration of the study period
Adequate renal, hepatic \& hematologic function
Negative Hepatitis B surface antigen test
Willing and able to provide written informed consent \& locator information

Exclusion Criteria for HIV-1 uninfected partner:

Current pregnancy, or planning to become pregnant during the study period
Currently breastfeeding
Concurrent enrollment in another HIV-1 vaccine or prevention trial
Receiving ongoing antiretroviral therapy
Repeated positive urine dipstick tests for glycosuria or proteinuria
Active and serious infections
History of pathological bone fractures not related to trauma

Inclusion Criteria for HIV-1 infected partner:

Partner within an HIV-1 discordant heterosexual relationship
One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
HIV-1 infected based on positive EIA
No history of any clinical AIDS-defining diagnoses
Plan to remain in the relationship for the duration of the study period
Willing and able to provide written informed consent \& locator information

Exclusion Criteria for HIV-1 infected partner:

Current use of antiretroviral therapy
Concurrent enrollment in another HIV-1 treatment trial

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 4,758 participants (actual)

Study arms

Active comparator
Tenofovir Disoproxil Fumarate (TDF)
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Drug: Tenofovir Disoproxil Fumarate (TDF)
Active comparator
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
Placebo comparator
Placebo
Placebo TDF + Placebo FTC/TDF orally, once daily.
Drug: Placebo

Interventions

DrugTenofovir Disoproxil Fumarate (TDF)
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Also known as: Viread + Placebo Truvada
DrugEmtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Also known as: Truvada + Placebo Viread
DrugPlacebo
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.
Also known as: Placebo + Placebo

What researchers measure

Primary outcomes

Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.
Time frame: Up to 36 months
Number of Participants With Serious Adverse Events (SAEs)
Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.
Time frame: Up to 36 months

Secondary outcomes

Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.
Time frame: Up to 36 months
Study Drug Adherence: Self-reported Missed Doses of Study Drug
Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.
Time frame: Up to 36 months
Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC
HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported. Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1).
Time frame: Up to 36 months
Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly. N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics).
Time frame: Up to 36 months
Prevalence of Unprotected Sex During Follow-up
Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.
Time frame: Up to 36 months
Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.
Time frame: Up to 36 months
Length Among Infants Born to Female Participants Taking Study Drug
The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Time frame: up to 12 months
Weight Among Infants Born to Female Participants Taking Study Drug
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Time frame: up to 12 months
Head Circumference Among Infants Born to Female Participants Taking Study Drug
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Time frame: up to 12 months

Results

Posted Nov 27, 2014

Participant flow

Participant flow — Overall Study
Milestone	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Started	1589	1583	1586
Completed	1577	1571	1574
Not completed	12	12	12
Withdrew: Lost to follow-up	7	8	10
Withdrew: Ineligible	5	4	2

Outcome measures

PrimaryIncidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants

The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.

Time frame:: Up to 36 months
Reported as:: Number · events per 100 person years

Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
events per 100 person years	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants	0.65 (0.38 to 1.05)	0.50 (0.27 to 0.85)	1.99 (1.49 to 2.62)

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Regression, Cox · p = <0.001 (The a priori threshold was 0.05.) · Hazard ratio (hr): 0.33 · 95% CI 0.19 to 0.56Placebo arm is the reference group.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Regression, Cox · p = <0.001 (The a priori threshold was 0.05.) · Hazard ratio (hr): 0.25 · 95% CI 0.13 to 0.45Placebo arm is the reference group.

PrimaryNumber of Participants With Serious Adverse Events (SAEs)

Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.

Time frame:: Up to 36 months
Reported as:: Number · Participants

Number of Participants With Serious Adverse Events (SAEs)
Participants	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Number of Participants With Serious Adverse Events (SAEs)	118	115	118

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Fisher Exact · p = 1.00
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Fisher Exact · p = 0.89

SecondaryStudy Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.

Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.

Time frame:: Up to 36 months
Reported as:: Number · percentage of doses taken of dispensed

Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
percentage of doses taken of dispensed	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.	97	97	97

SecondaryStudy Drug Adherence: Self-reported Missed Doses of Study Drug

Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.

Time frame:: Up to 36 months
Reported as:: Number · percentage of visits

Study Drug Adherence: Self-reported Missed Doses of Study Drug
percentage of visits	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Missed any doses	15	15	15
Missed 2+ consecutive doses	4	4	4

SecondaryNumber of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC

HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported. Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1).

Time frame:: Up to 36 months
Reported as:: Number · Participants

Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC
Participants	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC	1	1	0

SecondaryNumber of Participants With a Sexually Transmitted Infection (STI) During Follow-up

Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly. N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics).

Time frame:: Up to 36 months
Reported as:: Number · participants

Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
participants	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up	102	76	85

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Regression, Logistic · p = 0.24Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Regression, Logistic · p = 0.49Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.

SecondaryPrevalence of Unprotected Sex During Follow-up

Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.

Time frame:: Up to 36 months
Reported as:: Number · percentage of visits

Prevalence of Unprotected Sex During Follow-up
percentage of visits	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Prevalence of Unprotected Sex During Follow-up	14	13	13

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Regression, Logistic · p = 0.32Generalized estimating equations, logistic link, with robust standard errors.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Regression, Logistic · p = 0.66Generalized estimating equations, logistic link, with robust standard errors.

SecondaryCongenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.

Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.

Time frame:: Up to 36 months
Reported as:: Number · Number of live-born infants

Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
Number of live-born infants	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.	4	4	5

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Regression, Logistic · p = 0.51Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Regression, Logistic · p = 0.86generalized estimating equations with logistic link to account for multiple pregnancies and multiple births

SecondaryLength Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.

Time frame:: up to 12 months
Reported as:: Number · z-score difference per study month

Length Among Infants Born to Female Participants Taking Study Drug
z-score difference per study month	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Length Among Infants Born to Female Participants Taking Study Drug	-0.006	0.036	-0.033

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Mixed Models Analysis · p = 0.42linear mixed-effects model
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Mixed Models Analysis · p = 0.08 · Slope difference over time: 0.07Placebo arm is the reference group.

SecondaryWeight Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.

Time frame:: up to 12 months
Reported as:: Number · z-score difference per study month

Weight Among Infants Born to Female Participants Taking Study Drug
z-score difference per study month	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Weight Among Infants Born to Female Participants Taking Study Drug	-0.021	0.009	-0.056

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Mixed Models Analysis · p = 0.02Linear mixed effects model
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Mixed Models Analysis · p = <0.001Linear mixed effects model

SecondaryHead Circumference Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.

Time frame:: up to 12 months
Reported as:: Number · z-score difference per study month

Head Circumference Among Infants Born to Female Participants Taking Study Drug
z-score difference per study month	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
Head Circumference Among Infants Born to Female Participants Taking Study Drug	-0.057	-0.005	-0.079

Statistical analysis

Tenofovir Disoproxil Fumarate (TDF) vs Placebo · Mixed Models Analysis · p = 0.35Linear mixed effects model
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) vs Placebo · Mixed Models Analysis · p = 0.008Linear mixed effects model

Adverse events

Collected over Up to 36 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tenofovir Disoproxil Fumarate (TDF)	—	118/1,584 (7.4%)	1,306/1,584 (82.4%)
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	—	115/1,579 (7.3%)	1,316/1,579 (83.3%)
Placebo	—	118/1,584 (7.4%)	1,297/1,584 (81.9%)

Most frequent serious events

Showing 10 of 138

Most frequent serious events
Event	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
MALARIAInfections and infestations	28/1584	28/1579	37/1584
ABORTION SPONTANEOUSPregnancy, puerperium and perinatal conditions	7/598	8/566	6/621
NEUTROPHIL COUNT DECREASEDInvestigations	13/1584	18/1579	10/1584
NORMAL DELIVERYPregnancy, puerperium and perinatal conditions	5/598	2/566	2/621
PELVIC INFLAMMATORY DISEASEInfections and infestations	3/598	0/566	0/621
ROAD TRAFFIC ACCIDENTInjury, poisoning and procedural complications	1/1584	5/1579	6/1584
HAEMOGLOBIN DECREASEDInvestigations	1/1584	5/1579	2/1584
PLATELET COUNT DECREASEDInvestigations	1/1584	5/1579	4/1584
PEPTIC ULCERGastrointestinal disorders	4/1584	1/1579	3/1584
URINARY TRACT INFECTIONInfections and infestations	4/1584	0/1579	1/1584

Most frequent other events

Showing 10 of 34

Most frequent other events
Event	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo
NEUTROPHIL COUNT DECREASEDInvestigations	598/1584	686/1579	577/1584
BLOOD PHOSPHORUS DECREASEDInvestigations	440/1584	460/1579	473/1584
MALARIAInfections and infestations	290/1584	267/1579	280/1584
HAEMOGLOBIN DECREASEDInvestigations	259/1584	230/1579	231/1584
PLATELET COUNT DECREASEDInvestigations	190/1584	188/1579	177/1584
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations	125/1584	159/1579	142/1584
PELVIC INFLAMMATORY DISEASEInfections and infestations	59/598	48/566	55/621
BLOOD BICARBONATE DECREASEDInvestigations	123/1584	118/1579	135/1584
RESPIRATORY TRACT INFECTIONInfections and infestations	108/1584	91/1579	114/1584
BLOOD CREATININE INCREASEDInvestigations	76/1584	107/1579	86/1584

Baseline characteristics

All randomized participants, less those who were found to be ineligible (n=11)

Age, Customized
Age, Customized(participants)	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo	Total
18-24 years	184	177	172	533
25-34 years	721	690	688	2099
35-44 years	480	498	513	1491
45 years and older	199	214	211	624

Sex: Female, Male
Sex: Female, Male(Participants)	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo	Total
Female	598	566	621	1785
Male	986	1013	963	2962

Region of Enrollment
Region of Enrollment(participants)	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo	Total
Kenya	700	698	697	2095
Uganda	884	881	887	2652

Percentage of participants who had unprotected sex in the past month
Percentage of participants who had unprotected sex in the past month(percentage of participants)	Tenofovir Disoproxil Fumarate (TDF)	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	Placebo	Total
Number	27.9	26.3	25.8	26.7

Study locations

9 sites

Moi University - Indiana University
Eldoret, Kenya
CMR, Kemri-UCSF
Kisumu, Kenya
Kenyatta National Hospital/University of Nairobi
Nairobi, Kenya
Partners in Prevention - Thika
Thika, Kenya
Kabwohe Clinical Research Center
Bushenyi, Uganda
Infectious Diseases Institute
Jinja, Uganda
Partners House-Infectious Disease Institute Ltd
Kampala, Uganda
The AIDS Support Organization (TASO)
Mbale, Uganda
The AIDS Support Organization - Tororo Field Station
Tororo, Uganda

References and documents

Publications

Mujugira A, Baeten JM, Donnell D, Ndase P, Mugo NR, Barnes L, Campbell JD, Wangisi J, Tappero JW, Bukusi E, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kidoguchi L, Panteleeff D, Krows M, Shah H, Revall J, Morrison S, Ondrejcek L, Ingram C, Coombs RW, Lingappa JR, Celum C; Partners PrEP Study Team. Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention. PLoS One. 2011;6(10):e25828. doi: 10.1371/journal.pone.0025828. Epub 2011 Oct 5. PubMed 21998703 ↗
Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11. PubMed 22784037 ↗
Saha A, Escuduero J, Layouni T, Richardson B, Hou S, Mugo N, Mujugira A, Celum C, Baeten JM, Lingappa J, John-Stewart GC, LaCourse SM, Shah JA. Mycobacterium tuberculosis-Specific T-Cell Responses Are Impaired During Late Pregnancy With Elevated Biomarkers of Tuberculosis Risk Postpartum. J Infect Dis. 2022 May 4;225(9):1663-1674. doi: 10.1093/infdis/jiab614. PubMed 34929030 ↗
Mugo NR, Eckert L, Magaret AS, Cheng A, Mwaniki L, Ngure K, Celum C, Baeten JM, Galloway DA, Wamalwa D, Wald A. Quadrivalent HPV vaccine in HIV-1-infected early adolescent girls and boys in Kenya: Month 7 and 12 post vaccine immunogenicity and correlation with immune status. Vaccine. 2018 Nov 12;36(46):7025-7032. doi: 10.1016/j.vaccine.2018.09.059. Epub 2018 Oct 5. PubMed 30297124 ↗
Mackelprang RD, Bamshad MJ, Chong JX, Hou X, Buckingham KJ, Shively K, deBruyn G, Mugo NR, Mullins JI, McElrath MJ, Baeten JM, Celum C, Emond MJ, Lingappa JR; Partners in Prevention HSV/HIV Transmission Study and the Partners PrEP Study Teams. Whole genome sequencing of extreme phenotypes identifies variants in CD101 and UBE2V1 associated with increased risk of sexually acquired HIV-1. PLoS Pathog. 2017 Nov 6;13(11):e1006703. doi: 10.1371/journal.ppat.1006703. eCollection 2017 Nov. Erratum In: PLoS Pathog. 2019 Feb 11;15(2):e1007588. doi: 10.1371/journal.ppat.1007588. PubMed 29108000 ↗
Mugwanya K, Baeten J, Celum C, Donnell D, Nickolas T, Mugo N, Branch A, Tappero J, Kiarie J, Ronald A, Yin M, Wyatt C; Partners PrEP Study Team. Low Risk of Proximal Tubular Dysfunction Associated With Emtricitabine-Tenofovir Disoproxil Fumarate Preexposure Prophylaxis in Men and Women. J Infect Dis. 2016 Oct 1;214(7):1050-7. doi: 10.1093/infdis/jiw125. Epub 2016 Mar 29. PubMed 27029778 ↗
Mugwanya KK, Wyatt C, Celum C, Donnell D, Mugo NR, Tappero J, Kiarie J, Ronald A, Baeten JM; Partners PrEP Study Team. Changes in glomerular kidney function among HIV-1-uninfected men and women receiving emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis: a randomized clinical trial. JAMA Intern Med. 2015 Feb;175(2):246-54. doi: 10.1001/jamainternmed.2014.6786. PubMed 25531343 ↗
Baeten JM, Donnell D, Mugo NR, Ndase P, Thomas KK, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kidoguchi L, Coombs RW, Hendrix C, Marzinke MA, Frenkel L, Haberer JE, Bangsberg D, Celum C; Partners PrEP Study Team. Single-agent tenofovir versus combination emtricitabine plus tenofovir for pre-exposure prophylaxis for HIV-1 acquisition: an update of data from a randomised, double-blind, phase 3 trial. Lancet Infect Dis. 2014 Nov;14(11):1055-1064. doi: 10.1016/S1473-3099(14)70937-5. Epub 2014 Oct 7. PubMed 25300863 ↗
Mugo NR, Hong T, Celum C, Donnell D, Bukusi EA, John-Stewart G, Wangisi J, Were E, Heffron R, Matthews LT, Morrison S, Ngure K, Baeten JM; Partners PrEP Study Team. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):362-71. doi: 10.1001/jama.2014.8735. PubMed 25038355 ↗
Celum C, Morrow RA, Donnell D, Hong T, Hendrix CW, Thomas KK, Fife KH, Nakku-Joloba E, Mujugira A, Baeten JM; Partners PrEP Study Team. Daily oral tenofovir and emtricitabine-tenofovir preexposure prophylaxis reduces herpes simplex virus type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial. Ann Intern Med. 2014 Jul 1;161(1):11-9. doi: 10.7326/M13-2471. Erratum In: Ann Intern Med. 2016 Dec 6;165(11):832. doi: 10.7326/L16-0549. PubMed 24979446 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00557245
Lead sponsor: University of Washington
Collaborators: Bill and Melinda Gates Foundation
Responsible party: Connie Celum (Professor, School of Medicine, Global Health, University of Washington) — Principal investigator
First posted: Nov 12, 2007
Start date: May 2008
Primary completion: Oct 2013
Completion: Oct 2013
Results posted: Nov 27, 2014
Last update: Apr 19, 2019

Study contacts

Connie Celum,, MD, MPH

study chair · University of Washington

Jared Baeten, MD, PhD

study director · University of Washington

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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