Trial · NCT00448669
Botswana TDF/FTC Oral HIV Prophylaxis Trial
NCT00448669, Phase 2, Phase 3, Completed, Centers for Disease Control and Prevention; results first posted 2020-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Botswana TDF/FTC Oral HIV Prophylaxis Trial. Trials, record NCT00448669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00448669
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Botswana TDF/FTC Oral HIV Prophylaxis Trial
- NCT number
- NCT00448669
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,219 participants, actual
- Lead sponsor
- Centers for Disease Control and Prevention
- Conditions
- HIV Infections
- Interventions
- Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg, Placebo Oral Tablet
- First posted
- 2007-03-19
- Last updated
- 2020-02-05
- Results first posted
- 2020-02-05
- Limitations and caveats
The rates of study completion were lower than predicted because more participants withdrew from the study, mostly due to relocation or conflicting obligations.Findings may not be generalizable to other populations.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms | Monthly, for up to 3 years | Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits. |
| Primary | HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms | Monthly, for up to 3 years | Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort). |
| Secondary | Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | 12 months | We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment. |
| Secondary | Rates of Adherence to Study Medication | 36 months | The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test. |
| Secondary | Antiretroviral (ARV) Resistance Patterns in Seroconverters | At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis | Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations. |
| Secondary | CD4 Evaluation After HIV Seroconversion | 1-year post seroconversion | Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms | Monthly, for up to 3 years | percentage of participants with AE | NUMBER | |
| PRIMARY | HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms | Monthly, for up to 3 years | Of the 1219, 3 were excluded from analysis because HIV-infected at the time of enrollment. | infections/100 person-years | NUMBER |
| SECONDARY | Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | 12 months | Of 1219, 19 excluded (3 HIV-infected at enrollment, 16 never started drug). Of the 1200, 24 reported no sex during study. Remaining total 1176 with \>=1 sex act included in analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rates of Adherence to Study Medication | 36 months | Percentage of pills taken | MEAN | |
| SECONDARY | Antiretroviral (ARV) Resistance Patterns in Seroconverters | At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | CD4 Evaluation After HIV Seroconversion | 1-year post seroconversion | cells/microliter | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms | TDF-FTC, Condoms, Risk Counseling | 91.2 | percentage of participants with AE | ||
| Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms | Placebo, Condoms, Risk Counseling | 88.2 | percentage of participants with AE | ||
| HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms | TDF-FTC, Condoms, Risk Counseling | 1.2 | infections/100 person-years | ||
| HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms | Placebo, Condoms, Risk Counseling | 3.1 | infections/100 person-years | ||
| Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | TDF-FTC, Condoms, Risk Counseling | Baseline | 124 | Participants | |
| Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | Placebo, Condoms, Risk Counseling | Baseline | 113 | Participants | |
| Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | TDF-FTC, Condoms, Risk Counseling | Month 1 | 94 | Participants | |
| Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | Placebo, Condoms, Risk Counseling | Month 1 | 86 | Participants | |
| Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | TDF-FTC, Condoms, Risk Counseling | Month 2 | 97 | Participants | |
| Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | Placebo, Condoms, Risk Counseling | Month 2 | 90 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TDF-FTC, Condoms, Risk Counseling | 611 | |
| Overall Study | STARTED | Placebo, Condoms, Risk Counseling | 608 | |
| Overall Study | COMPLETED | TDF-FTC, Condoms, Risk Counseling | 393 | |
| Overall Study | COMPLETED | Placebo, Condoms, Risk Counseling | 410 | |
| Overall Study | NOT COMPLETED | TDF-FTC, Condoms, Risk Counseling | 218 | |
| Overall Study | NOT COMPLETED | Placebo, Condoms, Risk Counseling | 198 |
Source ClinicalTrials.gov
Adverse events192
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 | Abnormal Menses | Reproductive system and breast disorders | TDF-FTC, Condoms, Risk Counseling | 54 | 611 | 68 |
| other | Abnormal Menses | Reproductive system and breast disorders | Placebo, Condoms, Risk Counseling | 64 | 608 | 79 |
| other | Abscess | Skin and subcutaneous tissue disorders | TDF-FTC, Condoms, Risk Counseling | 13 | 611 | 13 |
| other | Abscess | Skin and subcutaneous tissue disorders | Placebo, Condoms, Risk Counseling | 17 | 608 | 18 |
| other | Acne | Skin and subcutaneous tissue disorders | TDF-FTC, Condoms, Risk Counseling | 11 | 611 | 11 |
| other | Acne | Skin and subcutaneous tissue disorders | Placebo, Condoms, Risk Counseling | 5 | 608 | 5 |
| other | Allergy, unspecified | General disorders | TDF-FTC, Condoms, Risk Counseling | 9 | 611 | 9 |
| other | Allergy, unspecified | General disorders | Placebo, Condoms, Risk Counseling | 6 | 608 | 6 |
| other | Anorexia | Gastrointestinal disorders | TDF-FTC, Condoms, Risk Counseling | 17 | 611 | 17 |
| other | Anorexia | Gastrointestinal disorders | Placebo, Condoms, Risk Counseling | 15 | 608 | 16 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TDF-FTC, Condoms, Risk Counseling | ||
| Total, all-cause mortality | Placebo, Condoms, Risk Counseling | ||
| Total, other adverse events | TDF-FTC, Condoms, Risk Counseling | 557 | 611 |
| Total, other adverse events | Placebo, Condoms, Risk Counseling | 536 | 608 |
| Total, serious adverse events | TDF-FTC, Condoms, Risk Counseling | 42 | 611 |
| Total, serious adverse events | Placebo, Condoms, Risk Counseling | 44 | 608 |
Source ClinicalTrials.gov
Papers7
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TDF-FTC, Condoms, Risk Counseling vs Placebo, Condoms, Risk Counseling: Antiretroviral (ARV) Resistance Patterns in Seroconverters | Trial comparisons |
| TDF-FTC, Condoms, Risk Counseling vs Placebo, Condoms, Risk Counseling: serious adverse events | 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00448669
GET https://conductscience.org/api/trials/v1/NCT00448669/results?page=2