HIV InfectionPhase 2/3NCT00111150
Botswana Tenofovir Oral HIV Prophylaxis Trial
A Phase 2/3 study testing Tenofovir Disoproxil Fumarate 300 mg daily in people with HIV Infection, run by Centers for Disease Control and Prevention at 2 sites in 2 countries.
Trial summary
This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Tenofovir Disoproxil Fumarate 300 mg daily
- How many people
- 1,200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2005to Mar 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- citizen of Botswana 18-29 years old
- sexually active
- HIV uninfected
- Hepatitis B and C uninfected
- Calculated creatinine clearance >= 60 mL/min
- hemoglobin >= 8 gm/dL
Show all 14Show fewer
- ALT and AST <= 2x ULN
- total bilirubin <= 1.5 mg/dL
- total serum amylase <= 1.5x ULN
- Serum phosphorus >= 2.2 mg/dL
- willing to use effective contraception
- living within 1 hours travel of study clinic
- pass comprehension test
- willing and able to give informed consent
Who cannot join
- history of significant renal or bone disease
- any chronic illness requiring ongoing prescription medication
- pregnant or breastfeeding
- planning to move away from site in the next year
- participating in another HIV prevention or vaccine safety trial
- any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
About this study
Official title: Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.
Read the detailed description
Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial will receive ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety will be monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board.
- Conditions
- HIV Infection
- Being tested
- Tenofovir Disoproxil Fumarate 300 mg daily
- Keywords
- HIV incidence, HIV prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate 300 mg dailyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug reactions in the tenofovir and placebo arms
HIV incidence in the tenofovir and placebo arms
Secondary outcomes (4)
Changes in levels of unprotected sex during the trial
Adherence to medication
Antiretroviral (ARV) resistance patterns in seroconverters
Viral set point in seroconverters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2005 (estimated)
- Study startSep 2005
- Study completionMar 2007
Why it stopped: Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Botswana Ministry of Health, Gilead Sciences
- Investigators
- Dawn K Smith, MD, MS, MPH, Study chair, CDC and BOTUSALynn A Paxton, MD, MPH, Study chair, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111150
- Sponsor's protocol ID
- CDC-NCHSTP-4321
- Other IDs
- BOTUSA MB04
- Status last verified
- Mar 2007
- First submitted
- 17 May 2005
- Last updated
- 19 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
- ClinicalTrials.gov ID
- NCT00111150
- Acronym / sponsor ID
- CDC-NCHSTP-4321
- Conditions
- HIV Infection
- Keywords
- HIV incidence, HIV prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial
- Enrolment
- 1,200 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Botswana Ministry of Health, Gilead Sciences
- Study start
- Sep 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 18 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.
Detailed description
Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial will receive ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety will be monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- citizen of Botswana 18-29 years old
- sexually active
- HIV uninfected
- Hepatitis B and C uninfected
- Calculated creatinine clearance >= 60 mL/min
Key exclusion criteria (6 listed)
- history of significant renal or bone disease
- any chronic illness requiring ongoing prescription medication
- pregnant or breastfeeding
- planning to move away from site in the next year
- participating in another HIV prevention or vaccine safety trial
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 |
|---|---|---|
| Tenofovir Disoproxil Fumarate 300 mg daily | Drug | – |
Primary outcome
Adverse drug reactions in the tenofovir and placebo arms
HIV incidence in the tenofovir and placebo arms
4 secondary outcomes
Changes in levels of unprotected sex during the trial
Adherence to medication
Antiretroviral (ARV) resistance patterns in seroconverters
Viral set point in seroconverters
Results and safety
The study was stopped early (reason given: Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2007.
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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.
Dawn K Smith, MD, MS, MPH study chair
CDC and BOTUSA
Lynn A Paxton, MD, MPH study chair
Centers for Disease Control and Prevention
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tenofovir Disoproxil Fumarate 300 mg daily in people with HIV Infection, run by Centers for Disease Control and Prevention at 2 sites in 2 countries.
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 14 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Botswana. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial). Results are not available in the source record.
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?
Adverse drug reactions in the tenofovir and placebo arms. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2007; AzTrials last refreshed its copy on 6 Nov 2026.