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

This study has been completed.
Sponsor:
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT00122486
First received: July 20, 2005
Last updated: July 28, 2006
Last verified: July 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase 2 Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

Resource links provided by NLM:


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.

Estimated Enrollment: 1200
Study Start Date: July 2004
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  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 ClinicalTrials.gov identifier: NCT00122486

Locations
Cameroon
Care and Health Program
Douala, Cameroon
Ghana
Virtual Access
Tema, Ghana
Nigeria
University of College Hospital
Ibadan, Nigeria
Sponsors and Collaborators
FHI 360
Investigators
Study Director: Leigh Peterson, PhD FHI 360
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00122486     History of Changes
Other Study ID Numbers: 9780
Study First Received: July 20, 2005
Last Updated: July 28, 2006
Health Authority: United States: Institutional Review Board

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 19, 2014