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Completed

NCT Number: NCT00448669

Botswana TDF/FTC Oral HIV Prophylaxis Trial

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.

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Key information

Conditions

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

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

BOTUSA HIV Prevention Research Unit, Gaborone, Botswana

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg

Drug

Other names: Truvada

Placebo oral tablet

Drug

Other names: Placebo

Primary outcomes

  1. Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms

    Time frame: Monthly, for up to 3 years

    Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits.

  2. HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms

    Time frame: Monthly, for up to 3 years

    Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort).

Secondary outcomes

  1. Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts

    Time frame: 12 months

    We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment.

  2. Rates of Adherence to Study Medication

    Time frame: 36 months

    The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test.

  3. Antiretroviral (ARV) Resistance Patterns in Seroconverters

    Time frame: At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis

    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.

  4. CD4 Evaluation After HIV Seroconversion

    Time frame: 1-year post seroconversion

    Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Botswana Ministry of Health
  • Gilead Sciences

Registry information

Official study 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

Acronym: TDF2

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 19, 2007
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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