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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
Sponsor:
Information provided by:
FHI 360

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
 (submitted: July 27, 2005)
  • Effectiveness endpoint is conversion for antibodies to HIV 1 or 2 as determined by an OMT test and confirmed by an ELISA from a finger prick or blood specimen. Discordant results between the OMT and the ELISA will be tested with WB.
  • Laboratory safety endpoints will include serum creatinine and phosphorus for kidney function, and AST and ALT for hepatic function. Reported adverse events will also be used for clinical evaluation of safety.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2005)
  • Effectiveness endpoint is conversion for antibodies to HIV 1 or 2 as determined by an OMT test and confirmed by an ELISA from a finger prick or blood specimen. Discordant results between the OMT and the ELISA will tested with WB.
  • Laboratory safety endpoints will include serum creatinine and phosphorus for kidney function, and AST and ALT for hepatic function. Reported adverse events will also be used for clinical evaluation of safety
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
 (submitted: July 28, 2006)
1200
Original Enrollment  ICMJE
 (submitted: July 20, 2005)
800
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV seronegative
  • Willing and able to give informed consent
  • 18 years to 35 years old, inclusive
  • Sexually active (on average, coitus 3 times per week)
  • Have had more than three sexual partners in the last month
  • Willing to use study product as directed
  • Willing to adhere to follow-up schedule
  • Willing to participate in the study for up to 12 months
  • Not pregnant, breast feeding, or desiring a pregnancy during the 12 months of participation
  • Have adequate renal function (serum creatinine < 1.5 mg/dL)
  • Have adequate liver function (hepatic transaminases [ALT and AST] < 43 U/L)
  • Have adequate serum phosphorus (greater than or equal to 2.2 mg/dL)
  • In general good health (no active, serious infections that require parenteral antibiotics; no active clinically significant medical conditions, including heart disease, diabetes, asthma, alcoholism, and cancer)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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
Study Director: Leigh Peterson, PhD FHI 360
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