Status:
COMPLETED
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-Risk Populations in Kenya, Africa
Lead Sponsor:
International AIDS Vaccine Initiative
Conditions:
HIV Infections
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the safety and acceptability of an intermittent and daily PrEP regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at risk for HIV, and i...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- Has understood the information provided and has provided written informed consent before any study-related procedures are performed
- Willing to undergo HIV testing, STI screening, HIV counselling and receive HIV and STI test results
- At risk for HIV infection as defined by at least one of the following:
- Current sexually-transmitted infection (STI) or STI in the previous 3 months
- In the past 3 months had multiple episodes of unprotected vaginal sex
- In the past 3 months had multiple episodes of unprotected anal sex
- In the past 3 months engaged in sex work for money or drugs
- If a female of childbearing potential (i.e., not post-menopausal or surgically sterile), using an effective method of non-barrier contraception (hormonal contraceptive; intrauterine device (IUD); surgical sterility) from 7 days prior to randomization until the end of the study. All female volunteers must be willing to undergo urine pregnancy tests
- Exclusion Criteria
- Confirmed HIV-1 or HIV-2 infection
- Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study, including severe infections requiring treatment such as tuberculosis, and alcohol or drug abuse
- Any of the following abnormal laboratory parameters:
- Haemoglobin \<9.0 g/dL
- Creatinine clearance \<80mL/min, as calculated by Cockcroft-Gault equation
- AST: \>2.5 x ULN
- ALT: \>2.5 x ULN
- Total bilirubin \>1.5 x ULN
- Serum amylase \>1.5 x ULN
- Serum phosphorus \<2.4 mg/dL
- Urinalysis: Two abnormal dipsticks showing any of the following:
- blood = 2+ or more (not due to menses)
- protein = 1+ or more
- leucocytes = 2+ or more
- glucose= 1+ or more
- Confirmed diagnosis of chronic hepatitis B infection (HBsAg positive)
- If female, pregnant or planning a pregnancy within 4 months after enrolment or lactating
- Participation in another clinical study of an investigational product currently, within the 3 months prior to enrolment or expected participation during this study
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00971230
Start Date
October 1 2009
End Date
July 1 2010
Last Update
August 9 2010
Active Locations (2)
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1
Kenya Medical Research Institute, Center for Geographic Medicine Research - Coast
Kilifi, Kilifi County, Kenya
2
Kenya AIDS Vaccine Initiative, University of Nairobi
Nairobi, Nairobi County, Kenya