Status:
COMPLETED
A Key Link for Transmission Prevention
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This pilot study will assess the feasibility for the potential public health benefit of behavioral and antiretroviral interventions during acute HIV infection. Central Hypothesis The investigators hy...
Detailed Description
The HIV epidemic in sub-Saharan Africa is severe and continues to grow. In urban areas of Malawi, 19% of pregnant women seeking antenatal care and 15.6% of Malawians aged 15-49 years were infected wit...
Eligibility Criteria
Inclusion
- Primary participants:
- Acute HIV-1 infection
- Men and women age greater than/= 18 years.
- Intention to remain in the Lilongwe area for the duration of the study.
- Ability and willingness of participant to provide informed consent.
- Willingness to provide contact/locator information, be contacted, and asked to return for AHI results.
- Partner Participants:
- Referred by a primary participant and present with a referral card.
- Had vaginal or anal sex with a primary participant within 12 weeks prior to that primary participant's enrolling
- Men and women age greater than/=18 years.
- remain in the Lilongwe area for the duration of the study.
- Ability and willingness of participant to provide informed consent.
Exclusion
- Primary Participants:
- HIV infection based on two positive HIV antibody rapid tests at the time of screening.
- HIV-negative based on one or more antibody rapid test and an HIV RNA PCR test.
- Serious illness, including tuberculosis or opportunistic infection, requiring systemic treatment and/or hospitalization.
- Active drug or alcohol use or dependence.
- Current imprisonment or involuntary incarceration.
- Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff, or would prevent proper conduct of the study.
- Partner Participants:
- Active drug or alcohol use or dependence.
- Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness.
- Exclusion for Receipt of Antiretroviral Drugs in the BIA Arm
- Note:A key component of this pilot study is to estimate the potential effect of ARVs during acute infection when applied on a large population scale.In effect, this pilot study should be viewed as a pilot for an effectiveness trial. Consequently, we will randomize all eligible participants to one of the three arms. If, however, persons should not receive ARVs for a variety of medically-related reasons, these persons will remain in the BIA arm, but will not receive ARVs. Women who are of reproductive potential but who refuse to use at least one form of contraception (see below), will remain in the BIA arm but will not receive ARVs. Similarly, persons randomized to the BI arm who do not attend all sessions will remain in the BI arm.
- Persons randomized to BIA with any of the following conditions will be excluded from receiving ARVs, but will remain in the BIA group for purposes of analysis.
- Laboratory values obtained at Day 0 prior to initiating ARVs at a subsequent visit
- Absolute neutrophil count \<300/mm3
- Hemoglobin \<8.0 g/dL
- Platelet count \<40,000/mm3
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase \> 5 x upper limit of normal (ULN)
- Total bilirubin \>2.5 x ULN
- Creatinine Clearance (CrCl) \<60 mL/min
- Hepatitis B surface antigen positivity
- Positive serum or urine pregnancy test at Day 0.
- Breastfeeding
- Refusal to use at least one method of contraception, if a woman is of reproductive potential.
- Acceptable forms of contraception include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, intrauterine device (IUD), or a hormonal-based contraceptive.
- Women not meeting the reproductive potential criteria above may receive the study drugs without using contraception.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Requirement for any current medications that are prohibited with any study drugs.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01450189
Start Date
October 1 2011
End Date
July 1 2014
Last Update
April 19 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Lighthouse Trust, Kamuzu Central Hospital
Lilongwe, Malawi
2
UNC Project
Lilongwe, Malawi