Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

• ClinicalTrials.gov Identifier: NCT00122486
• Recruitment Status: Completed
• First Posted: July 22, 2005
• Last Update Posted: August 1, 2006
• Sponsor: FHI 360
• Information provided by: FHI 360

Tracking Information

• First Submitted Date: July 20, 2005
• First Posted Date: July 22, 2005
• Last Update Posted Date: August 1, 2006
• Study Start Date: July 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
• Condition: HIV Infections
• Intervention: Drug: Tenofovir Disoproxil Fumarate
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: July 28, 2006): 1200
• Original Enrollment (submitted: July 20, 2005): 800
• Study Completion Date: March 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Cameroon, Ghana, Nigeria

Administrative Information

• NCT Number: NCT00122486
• Other Study ID Numbers: 9780
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: FHI 360
• Collaborators: Not Provided

Investigators

• Study Director: Leigh Peterson, PhD; FHI 360

• PRS Account: FHI 360
• Verification Date: July 2006