- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00122486
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
Phase 2 Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Leigh Peterson, PhD, FHI 360
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Human Immunodeficiency Virus
- 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
- 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
- IU international units
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- 9780 (CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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