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Status:

COMPLETED

FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

Lead Sponsor:

FHI 360

Conditions:

HIV Infections

Eligibility:

FEMALE

18-35 years

Phase:

PHASE3

Brief Summary

This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the s...

Detailed Description

This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the s...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial
  • Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly
  • Between 18-35 years old, inclusive
  • At higher risk of becoming HIV infected
  • Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm
  • Willing to participate in all aspects of the study and to comply with study procedures, for up to 60 weeks, including:
  • Be randomized
  • Use study product as directed
  • Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)
  • Use a study-approved effective non-barrier method of contraception for the duration of the study
  • Take study product, as evidenced by swallowing a vitamin tablet that is similar in size to the study product at enrollment
  • Provide contact information and agrees to some form of contact method throughout the study
  • Not intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area ( \> 1 month at a time)
  • In general good health and have no condition (social or medical) which, in the opinion of the Site Investigator, would make study participation unsafe or complicate data interpretation
  • Not pregnant or breastfeeding, and does not anticipate a desire for pregnancy during the 52 weeks of on-product participation
  • Medically eligible at screening including:
  • Adequate renal function (serum creatinine ≤ upper limit of normal (ULN) of local range and creatinine clearance ≥ 60ml/min estimated by the Cockcroft-Gault Creatinine Clearance Formula
  • Adequate hepatic function (hepatic transaminases ALT and AST \< 2x ULN \[according to local normal ranges\])
  • HBsAg negative
  • Serum phosphorus levels above the lower limit of the local normal range (according to local normal ranges - grade 3 \& 4 hypophosphatemia will be excluded even if within normal local ranges)
  • Not received or receiving an experimental HIV vaccine, participating in another HIV prevention study or participating in any other clinical trial with a biomedical intervention
  • No clinical signs of liver disease (e.g., ascites, spider angiomata, hepatomegaly, jaundice)
  • No definite evidence of glycosuria or proteinuria (i.e., no repeated positive \[ ≥ + 1 \] urine dipstick). If a urine dipstick is positive for either glucose and/or protein at the first test, a second urine sample will be tested.
  • No history of pathological bone fractures
  • No history of adverse reaction to latex
  • Not taking any of the following medications: nephrotoxic agents; aminoglycoside antibiotics (including gentamicin); intravenous (IV) amphotericin B; cidofovir; cisplatin; foscarnet; IV pentamidine; oral or IV vancomycin; oral or IV gancyclovir; other agents with significant nephrotoxic potential; drugs that slow renal excretion; probenecid; immune system modulators; systemic chemotherapeutic agents (i.e. cancer treatment medications); systemic corticosteroids; interleukin-2 (IL-2); immunomodulators; interferon (alpha, beta, or gamma); other antiretrovirals (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)

Exclusion

    Key Trial Info

    Start Date :

    May 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2013

    Estimated Enrollment :

    2120 Patients enrolled

    Trial Details

    Trial ID

    NCT00625404

    Start Date

    May 1 2009

    End Date

    January 1 2013

    Last Update

    July 26 2018

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Bondo Clinic, Bondo District Hospital

    Bondo, Nyanza, Kenya

    2

    Setshaba Research Centre

    Pretoria, Gauteng, South Africa

    3

    Josha Research Center

    Bloemfontein, South Africa

    4

    Arusha Clinic, Levolosi Health Center

    Arusha, Tanzania