Trial · NCT00557245
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
NCT00557245, Phase 3, Completed, University of Washington; results first posted 2014-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples. Trials, record NCT00557245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00557245
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
- NCT number
- NCT00557245
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,758 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- HIV-1 Infections, HIV Infections
- Interventions
- Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
- First posted
- 2007-11-12
- Last updated
- 2019-04-19
- Results first posted
- 2014-11-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants | Up to 36 months | 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. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Up to 36 months | 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. |
| Secondary | Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses. | Up to 36 months | 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. |
| Secondary | Study Drug Adherence: Self-reported Missed Doses of Study Drug | Up to 36 months | 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. |
| Secondary | Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC | Up to 36 months | 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). |
| Secondary | Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up | Up to 36 months | 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). |
| Secondary | Prevalence of Unprotected Sex During Follow-up | Up to 36 months | Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up. |
| Secondary | Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug. | Up to 36 months | Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies. |
| Secondary | Length Among Infants Born to Female Participants Taking Study Drug | up to 12 months | 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. |
| Secondary | Weight Among Infants Born to Female Participants Taking Study Drug | up to 12 months | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants | Up to 36 months | All randomized participants, less those who were found to ineligible (n=11), less those found to be infected at enrollment (n=14), and less those who did not return for any follow-up (n=25). | events per 100 person years | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | Up to 36 months | Randomized participants, less those found to be ineligible (n=11) | Participants | NUMBER |
| SECONDARY | Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses. | Up to 36 months | percentage of doses taken of dispensed | NUMBER | |
| SECONDARY | Study Drug Adherence: Self-reported Missed Doses of Study Drug | Up to 36 months | Participants with self-reported adherence. | percentage of visits | NUMBER |
| SECONDARY | Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC | Up to 36 months | Participants who seroconverted during the Partners PrEP trial, including those who were retrospectively found to be HIV infected at enrollment (TDF arm: n=5; FTC-TDF arm: n=3; placebo arm: n=6). For 4 of 96 HIV-1 seroconverters (TDF arm: n=2; FTC-TDF arm: n=1; placebo arm: n=1) HIV-1 RNA was unable to be amplified for HIV-1 resistance testing. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up | Up to 36 months | Randomized participants, less those found to be ineligible (n=11) | participants | NUMBER |
| SECONDARY | Prevalence of Unprotected Sex During Follow-up | Up to 36 months | All randomized participants, less those found to be ineligible (n=11). | percentage of visits | NUMBER |
| SECONDARY | Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug. | Up to 36 months | Randomized female participants, less those found to be ineligible (n=7) | Number of live-born infants | NUMBER |
| SECONDARY | Length Among Infants Born to Female Participants Taking Study Drug | up to 12 months | Infants born to women taking study drug during follow-up | z-score difference per study month | NUMBER |
| SECONDARY | Weight Among Infants Born to Female Participants Taking Study Drug | up to 12 months | Infants born to women taking study drug during follow-up | z-score difference per study month | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants | Tenofovir Disoproxil Fumarate (TDF) | 0.65 | 95% Confidence Interval 0.38 to 1.05 | events per 100 person years | |
| Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0.50 | 95% Confidence Interval 0.27 to 0.85 | events per 100 person years | |
| Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants | Placebo | 1.99 | 95% Confidence Interval 1.49 to 2.62 | events per 100 person years | |
| Number of Participants With Serious Adverse Events (SAEs) | Tenofovir Disoproxil Fumarate (TDF) | 118 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 115 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Placebo | 118 | Participants | ||
| Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses. | Tenofovir Disoproxil Fumarate (TDF) | 97 | percentage of doses taken of dispensed | ||
| Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses. | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 97 | percentage of doses taken of dispensed | ||
| Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses. | Placebo | 97 | percentage of doses taken of dispensed | ||
| Study Drug Adherence: Self-reported Missed Doses of Study Drug | Tenofovir Disoproxil Fumarate (TDF) | Missed any doses | 15 | percentage of visits |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tenofovir Disoproxil Fumarate (TDF) | 1,589 | |
| Overall Study | STARTED | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1,583 | |
| Overall Study | STARTED | Placebo | 1,586 | |
| Overall Study | COMPLETED | Tenofovir Disoproxil Fumarate (TDF) | 1,577 | |
| Overall Study | COMPLETED | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1,571 | |
| Overall Study | COMPLETED | Placebo | 1,574 | |
| Overall Study | NOT COMPLETED | Tenofovir Disoproxil Fumarate (TDF) | 12 | |
| Overall Study | NOT COMPLETED | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events516
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NEUTROPHIL COUNT DECREASED | Investigations | Tenofovir Disoproxil Fumarate (TDF) | 598 | 1,584 | 1,109 |
| other | NEUTROPHIL COUNT DECREASED | Investigations | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 686 | 1,579 | 1,322 |
| other | NEUTROPHIL COUNT DECREASED | Investigations | Placebo | 577 | 1,584 | 1,076 |
| other | BLOOD PHOSPHORUS DECREASED | Investigations | Tenofovir Disoproxil Fumarate (TDF) | 440 | 1,584 | 763 |
| other | BLOOD PHOSPHORUS DECREASED | Investigations | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 460 | 1,579 | 785 |
| other | BLOOD PHOSPHORUS DECREASED | Investigations | Placebo | 473 | 1,584 | 787 |
| other | MALARIA | Infections and infestations | Tenofovir Disoproxil Fumarate (TDF) | 290 | 1,584 | 371 |
| other | MALARIA | Infections and infestations | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 267 | 1,579 | 356 |
| other | MALARIA | Infections and infestations | Placebo | 280 | 1,584 | 352 |
| other | HAEMOGLOBIN DECREASED | Investigations | Tenofovir Disoproxil Fumarate (TDF) | 259 | 1,584 | 384 |
1 to 10 of 516Source ClinicalTrials.gov
See all 516 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenofovir Disoproxil Fumarate (TDF) | ||
| Total, all-cause mortality | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tenofovir Disoproxil Fumarate (TDF) | 1,306 | 1,584 |
| Total, other adverse events | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1,316 | 1,579 |
| Total, other adverse events | Placebo | 1,297 | 1,584 |
| Total, serious adverse events | Tenofovir Disoproxil Fumarate (TDF) | 118 | 1,584 |
| Total, serious adverse events | Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 115 | 1,579 |
| Total, serious adverse events | Placebo | 118 | 1,584 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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