Clinical Trials


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

This study has been completed
FHI 360

Information provided by (Responsible Party)
FHI 360 Identifier

First received: July 20, 2005
Last updated: July 28, 2006
Last Verified: July 2006
History of Changes


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.

Condition Intervention Phase
HIV Infections

Drug : Tenofovir Disoproxil Fumarate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase 2 Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

Further study details as provided by FHI 360:

Primary Outcome Measures

  • 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.

Enrollment: 1200
Study Start Date: July 2004
Study Completion Date: March 2006

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.



Ages Eligible for Study: 18 Years to 35 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  


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)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00122486


Care and Health Program
Douala, Cameroon
Virtual Access
Tema, Ghana
University of College Hospital
Ibadan, Nigeria

Sponsors and Collaborators

FHI 360


Study Director: Leigh Peterson, PhD FHI 360
More Information

More Information

Responsible Party: FHI 360 Identifier: NCT00122486   History of Changes  
Other Study ID Numbers: 9780  
Study First Received: July 20, 2005  
Last Updated: July 28, 2006  

Keywords provided by FHI 360:

AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonisation
IND Investigational New Drug Application
IRB Institutional Review Board
IU international units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
WB Western Blot
Human Immunodeficiency Virus

Additional relevant MeSH terms:
HIV Infections
Tenofovir processed this data on June 02, 2020
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