Status:
COMPLETED
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
Lead Sponsor:
International AIDS Vaccine Initiative
Conditions:
HIV Infection
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the safety and acceptability of intermittent and daily pre-exposure prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV discordant co...
Eligibility Criteria
Inclusion
- Inclusion Criteria (for HIV-uninfected volunteers):
- Willing to comply with the protocol and available for follow-up for the study duration
- Has understood the information provided and has provided written informed consent before any study-related procedures are performed
- Willing to undergo couple HIV testing, sexually transmitted infection (STI) screening, HIV counseling and receive test results, and share results with partner
- At risk for HIV infection as defined by: has an HIV-infected partner not using ART in the past 3 months and had episodes of unprotected sex with partner in the past 3 months
- If a female of childbearing potential:
- 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
- HIV-infected partner is willing and eligible to enroll in the study
- Inclusion Criteria (for HIV-1 infected partner):
- HIV-1 infected partner of an HIV-uninfected volunteer who meets study eligibility
- Plan to remain in the relationship for the duration of the study period
- Willing and able to provide written informed consent \& locator information
- Exclusion Criteria (for HIV-uninfected volunteer):
- Confirmed HIV-1 or HIV-2 infection
- Any clinically significant acute or chronic medical condition that is considered progressive, including severe infections requiring treatment such as tuberculosis, and alcohol or drug abuse
- Any of the following abnormal lab 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 a product currently, or within the 3 mo. prior to enrolment
- Exclusion Criteria (for HIV-1 infected partner):
- Current use of antiretroviral therapy
- Concurrent enrollment in another HIV treatment trial
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00931346
Start Date
October 1 2009
End Date
October 1 2010
Last Update
August 25 2011
Active Locations (1)
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1
MRC-Entebbe
Entebbe, Entebbe, Uganda