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Botswana TDF/FTC Oral HIV Prophylaxis Trial (TDF2)

This study has been completed.
Sponsor:
Collaborators:
Botswana Ministry of Health
Gilead Sciences
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00448669
First received: March 16, 2007
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.


Condition Intervention Phase
HIV Infections
Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg
Drug: TDF-FTC placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Adverse drug reactions in the tenofovir/emtricitabine and placebo arms; [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
    Participants reported any adverse effects at monthly visits.

  • HIV incidence in the tenofovir/emtricitabine and placebo arms [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
    Participants HIV status was checked monthly


Secondary Outcome Measures:
  • Secondary: Changes in levels of unprotected sex during the trial; [ Time Frame: quarterly ] [ Designated as safety issue: No ]
    Participants provided information about their sexual activity on a quarterly basis

  • Adherence to medication; [ Time Frame: monthly ] [ Designated as safety issue: No ]
    Participants provided information about their adherence to medication on a quarterly basis. Pill counts were done monthly.

  • Antiretroviral (ARV) resistance patterns in seroconverters; [ Time Frame: at time of seroconversion ] [ Designated as safety issue: Yes ]
    Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations.

  • Viral set point in seroconverters [ Time Frame: At time of seroconversion and six months afterward ] [ Designated as safety issue: Yes ]
    Participants who HIV seroconverted during the study had their CD4 count evaluated at the time of seroconversion and at 6 months post seroconversion.


Enrollment: 1219
Study Start Date: March 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TDF-FTC, condoms, risk counseling
Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg
Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.
Other Name: Truvada
Placebo Comparator: Placebo, condoms, risk counseling
Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
Drug: TDF-FTC placebo
Placebo comparator for TDF-FTC

Detailed Description:

Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers were randomized to receive either Tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day. Volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial received ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety was monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • citizen of Botswana 18-39 years old
  • sexually active
  • HIV uninfected
  • Hepatitis B and C uninfected
  • Calculated creatinine clearance >= 60 mL/min
  • hemoglobin >= 8 gm/dL
  • ALT and AST <= 2x ULN
  • total bilirubin <= 1.5 mg/dL
  • total serum amylase <= 1.5x ULN
  • Serum phosphorus >= 2.2 mg/dL
  • willing to use hormonal contraception (females)
  • living within 1 hours travel of study clinic
  • pass comprehension test
  • willing and able to give informed consent

Exclusion Criteria:

  • 18-20 without parent/guardian consent
  • history of significant renal or bone disease
  • any chronic illness requiring ongoing prescription medication
  • pregnant or breastfeeding
  • planning to move away from site in the next year
  • participating in another HIV prevention or vaccine safety trial
  • any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
  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: NCT00448669

Locations
United States, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
Botswana
BOTUSA HIV Prevention Research Unit
Francistown and Gaborone, Botswana
Sponsors and Collaborators
Botswana Ministry of Health
Gilead Sciences
Investigators
Principal Investigator: Lynn A Paxton, MD, MPH Centers for Disease Control and Prevention
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00448669     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-4940, BOTUSA MB06
Study First Received: March 16, 2007
Last Updated: October 1, 2012
Health Authority: United States: Federal Government
Botswana: Ministry of Health

Keywords provided by Centers for Disease Control and Prevention:
HIV incidence
HIV prevention
Tenofovir
Emtricitabine
Botswana
HIV seronegativity

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

ClinicalTrials.gov processed this record on November 27, 2014