HIV InfectionsPhase 2/3NCT00078182
Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
A Phase 2/3 study testing Tenofovir DF in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Cambodia.
Trial summary
Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Seronegativity
- What is being tested?
- Tenofovir DF
- How many people
- 0 participants
- Where
- 1 siteCambodia
- Study dates
- Start not givento not given
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV uninfected
- Report receiving money or gifts for vaginal or anal sexual intercourse in the year prior to study entry
- Able to provide a street address of residence for themselves and two personal contacts who would know their whereabouts during the study period
- Normal lab values within 14 days of study entry
- Ability to understand spoken Khmer
- Willing and able to provide written informed consent
Who cannot join
- Pregnant or breast-feeding
- Previously diagnosed active or serious infections
- Certain medications
- Active alcohol or drug abuse that could interfer with the study
- Previously diagnosed malignancies other than basal cell carcinoma
- Any other condition that, in the opinion of the study officials, would preclude informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Daily Oral Tenofovir (Tenofovir Disoproxil Fumarate) to Prevent HIV-1 Infection Among Sex Workers in Cambodia
Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.
Read the detailed description
Cambodia has one of the highest rates of HIV infection in Southeast Asia. At the end of 2002, HIV infection rates among Cambodian sex workers ranged from 14.8% to 28.8%. Tenofovir DF is a nucleotide reverse transcriptase inhibitor (NRTI) that was licensed for the treatment of HIV-1 infection by the United States Food and Drug Administration (FDA) in October 2001. This randomized clinical trial will determine if a daily oral 300 mg dose of tenofovir DF is safe and effective in preventing HIV-1 infection. This is a collaborative study between the University of California, San Francisco, the University of New South Wales, and the Ministry of Health of Cambodia.
Nine hundred and sixty HIV uninfected female sex workers in Phnom Penh will be enrolled in the trial. Participants will be randomized to receive either 300 mg of tenofovir DF or placebo daily for 12 months. Participants will be evaluated for rates of HIV infection, adherence to the drug regimen, and changes in risk behaviors. All participants will be monitored throughout the trial for side effects and toxicity. Participants will be involved in the study for 14 months.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- Tenofovir DF
- Keywords
- 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 DFDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- NCHADS - Ministry of Health of Cambodia, Kirby Institute
- Investigators
- Kimberly Shafer, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078182
- Sponsor's protocol ID
- 1U01AI054241-01
- Status last verified
- May 2005
- First submitted
- 19 Feb 2004
- Last updated
- 14 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Daily Oral Tenofovir (Tenofovir Disoproxil Fumarate) to Prevent HIV-1 Infection Among Sex Workers in Cambodia
- ClinicalTrials.gov ID
- NCT00078182
- Acronym / sponsor ID
- 1U01AI054241-01
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- HIV Prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- NCHADS - Ministry of Health of Cambodia, Kirby Institute
- First posted
- 20 Feb 2004 (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.
Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.
Detailed description
Cambodia has one of the highest rates of HIV infection in Southeast Asia. At the end of 2002, HIV infection rates among Cambodian sex workers ranged from 14.8% to 28.8%. Tenofovir DF is a nucleotide reverse transcriptase inhibitor (NRTI) that was licensed for the treatment of HIV-1 infection by the United States Food and Drug Administration (FDA) in October 2001. This randomized clinical trial will determine if a daily oral 300 mg dose of tenofovir DF is safe and effective in preventing HIV-1 infection. This is a collaborative study between the University of California, San Francisco, the University of New South Wales, and the Ministry of Health of Cambodia.
Nine hundred and sixty HIV uninfected female sex workers in Phnom Penh will be enrolled in the trial. Participants will be randomized to receive either 300 mg of tenofovir DF or placebo daily for 12 months. Participants will be evaluated for rates of HIV infection, adherence to the drug regimen, and changes in risk behaviors. All participants will be monitored throughout the trial for side effects and toxicity. Participants will be involved in the study for 14 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV uninfected
- Report receiving money or gifts for vaginal or anal sexual intercourse in the year prior to study entry
- Able to provide a street address of residence for themselves and two personal contacts who would know their whereabouts during the study period
- Normal lab values within 14 days of study entry
- Ability to understand spoken Khmer
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding
- Previously diagnosed active or serious infections
- Certain medications
- Active alcohol or drug abuse that could interfer with the study
- Previously diagnosed malignancies other than basal cell carcinoma
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 DF | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
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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.
Kimberly Shafer, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tenofovir DF in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Cambodia.
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 6 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: withdrawn, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. 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 withdrawn before enrolling participants, so there are no results.
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.
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 14 Dec 2016.