Trial · NCT00705679
Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
NCT00705679, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2016-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women. Trials, record NCT00705679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00705679
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women
- NCT number
- NCT00705679
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5,029 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
Emtricitabine/tenofovir disoproxil fumarate, Emtricitabine/tenofovir disoproxil fumarate placebo, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate placebo, Tenofovir 1% vaginal gel, Tenofovir placebo
- First posted
- 2008-06-26
- Last updated
- 2021-10-29
- Results first posted
- 2016-02-10
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | 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. |
| Primary | Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | 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). |
| Primary | Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | 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). |
| Primary | Person-years of Follow-up of Oral TDF and Oral Placebo Arms | 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. |
| Primary | Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms | 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). |
| Primary | Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms | 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). |
| Primary | Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms | 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. |
| Primary | Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms | 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). |
| Primary | Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms | 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). |
| Primary | 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 | 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 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 | Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | For up to 30 months of follow-up | 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. | person-years | NUMBER |
| PRIMARY | Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | For up to 30 months of follow-up | 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. | participants | NUMBER |
| SECONDARY | Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product | Throughout study, up to 2.5 years | Resistance testing was successfully completed on plasma from 301/312 HIV-1 seroconverters while on study product. 11 participants did not have a resistance result due to no stored plasma, insufficient copies of HIV-1 RNA for extraction, or PCR amplification failure. | participants | NUMBER |
| PRIMARY | Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | For up to 30 months of follow-up | 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. | cases per 100 person-years | NUMBER |
| PRIMARY | Person-years of Follow-up of Oral TDF and Oral Placebo Arms | For up to 30 months of follow-up | 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. | person-years | NUMBER |
| PRIMARY | Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms | For up to 30 months of follow-up | 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. | participants | NUMBER |
| PRIMARY | Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms | For up to 30 months of follow-up | 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. | cases per 100 person-years | NUMBER |
| PRIMARY | Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms | For up to 30 months of follow-up | 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. | person-years | NUMBER |
| PRIMARY | Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms | For up to 30 months of follow-up | 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. | participants | NUMBER |
| PRIMARY | Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms | For up to 30 months of follow-up | 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. | cases per 100 person-years | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | TFV Gel | 1024 | person-years | ||
| Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | Placebo Gel | 1030 | person-years | ||
| Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | TFV Gel | 61 | participants | ||
| Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | Placebo Gel | 70 | participants | ||
| Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product | Oral TDF | M184V mutation | 0 | participants | |
| Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product | Oral TDF-FTC | M184V mutation | 1 | participants | |
| Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product | Oral Placebo | M184V mutation | 0 | participants | |
| Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product | TFV Gel | M184V mutation | 0 | participants | |
| Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product | Gel Placebo | M184V mutation | 0 | participants | |
| Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product | Oral TDF | No M184V mutation | 58 | participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral TDF | 1,007 | |
| Overall Study | STARTED | Oral TDF-FTC | 1,003 | |
| Overall Study | STARTED | Oral Placebo | 1,009 | |
| Overall Study | STARTED | TFV Gel | 1,007 | |
| Overall Study | STARTED | Gel Placebo | 1,003 | |
| Overall Study | COMPLETED | Oral TDF | 942 | |
| Overall Study | COMPLETED | Oral TDF-FTC | 864 | |
| Overall Study | COMPLETED | Oral Placebo | 894 | |
| Overall Study | COMPLETED | TFV Gel | 927 | |
| Overall Study | COMPLETED | Gel Placebo | 934 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events615
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 | Genitourinary chlamydia infection | Infections and infestations | Oral TDF | 105 | 1,007 | |
| other | Genitourinary chlamydia infection | Infections and infestations | Oral TDF-FTC | 144 | 1,003 | |
| other | Genitourinary chlamydia infection | Infections and infestations | Oral Placebo | 154 | 1,009 | |
| other | Genitourinary chlamydia infection | Infections and infestations | TFV Gel | 100 | 1,007 | |
| other | Genitourinary chlamydia infection | Infections and infestations | Gel Placebo | 107 | 1,003 | |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Oral TDF | 26 | 1,007 | |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Oral TDF-FTC | 46 | 1,003 | |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Oral Placebo | 45 | 1,009 | |
| other | Genitourinary tract gonococcal infection | Infections and infestations | TFV Gel | 40 | 1,007 | |
| other | Genitourinary tract gonococcal infection | Infections and infestations | Gel Placebo | 32 | 1,003 |
1 to 10 of 615Source ClinicalTrials.gov
See all 615 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral TDF | ||
| Total, all-cause mortality | Oral TDF-FTC | ||
| Total, all-cause mortality | Oral Placebo | ||
| Total, all-cause mortality | TFV Gel | ||
| Total, all-cause mortality | Gel Placebo | ||
| Total, other adverse events | Oral TDF | 646 | 1,007 |
| Total, other adverse events | Oral TDF-FTC | 740 | 1,003 |
| Total, other adverse events | Oral Placebo | 747 | 1,009 |
| Total, other adverse events | TFV Gel | 705 | 1,007 |
| Total, other adverse events | Gel Placebo | 715 | 1,003 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI068633 | Microbicide Trials Network | HILLIER, SHARON L. | MAGEE-WOMEN'S RES INST AND FOUNDATION | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral TDF-FTC vs Oral Placebo: Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms | Trial comparisons |
| Oral TDF vs Oral Placebo: Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms | Trial comparisons |
| TFV Gel vs Placebo Gel: Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms | Trial comparisons |
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.
For software
Read this trial from software.
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