Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00122486 |
Recruitment Status :
Completed
First Posted : July 22, 2005
Last Update Posted : August 1, 2006
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | July 20, 2005 | |||
First Posted Date ICMJE | July 22, 2005 | |||
Last Update Posted Date | August 1, 2006 | |||
Study Start Date ICMJE | July 2004 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV | |||
Official Title ICMJE | Phase 2 Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV | |||
Brief Summary | This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected. | |||
Detailed Description | The protocol describes a randomized, fully-masked, parallel, placebo-controlled study of TDF for pre-exposure prophylaxis of HIV in high-risk women. TDF was selected for investigation as prophylaxis against HIV in high-risk women because of its unique pharmacological profile. In addition to the convenience of being a once daily single tablet, TDF's safety profile is comparable to placebo among HIV infected persons, it has striking anti-HIV potency, and it has low potential for selection of resistant viruses. TDF is cleared from the body by the kidneys and is not metabolized by the liver. Therefore, TDF has limited potential to have pharmacokinetic interactions with other hepatically metabolized drugs. Each of these properties is necessary given the realities of the intended target populations. Moreover, initial prevention studies in simian models have provided encouraging results. Finally, the drug's sponsor is supportive of investigating the potential use of TDF as a preventive, as well as a therapeutic agent. Participants' HIV status is monitored monthly. Participants are also monitored for safety using periodic physical examinations, serial laboratory tests and adverse event queries. Lab tests for kidney and liver function were to be conducted at screening, months 1, 3 and every 3 months thereafter or at the final visit if early withdrawal. To minimize the risk of contracting HIV infection, participants are counseled monthly to use male condoms for each act of intercourse. Participants converting for antibodies to HIV are counseled and referred to medical services as appropriate for each country. |
|||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
|||
Condition ICMJE | HIV Infections | |||
Intervention ICMJE | Drug: Tenofovir Disoproxil Fumarate | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
1200 | |||
Original Enrollment ICMJE |
800 | |||
Study Completion Date ICMJE | March 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 35 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Cameroon, Ghana, Nigeria | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00122486 | |||
Other Study ID Numbers ICMJE | 9780 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | FHI 360 | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | FHI 360 | |||
Verification Date | July 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |