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

NCT00122486 | Completed Phase 2

• 1 other identifier: 9780
• Study Type: interventional
• Target: 1,200
• Locations: 3 countries
• Sites: 3

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

Tenofovir Disoproxil Fumarate DRUG

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV seronegative
• Willing and able to give informed consent
• 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)

Sponsors & Collaborators

• FHI 360: lead

Study Sites (3)

Care and Health Program

Douala, Cameroon

Location

Virtual Access

Tema, Ghana

Location

University of College Hospital

Ibadan, Nigeria

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Leigh Peterson, PhD

  FHI 360

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2005
• First Posted: July 22, 2005
• Study Start: July 1, 2004
• Study Completion: March 1, 2006
• Last Updated: August 1, 2006

Record last verified: 2006-07

Locations

GH (1); NG (1); CA (1)