A Key Link for Transmission Prevention
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01450189 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard HIV prevention messages (Behavioral); BI: Information-Motivation-Behavioral Skills Model (Behavioral); Raltegravir (Drug); emtricitabine/tenofovir disoproxil fumarate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening |
0.622 | — |
| PRIMARY Prevalence of AHI Among Persons Screened |
0.0073 | — |
| PRIMARY Proportion of Persons With AHI Successfully Recruited Into the Study |
0.69 | — |
| PRIMARY Proportion of Participants Completing Full Course of ARVs in Arm BIA |
0.917 | — |
| PRIMARY Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment. |
0.216 | — |
| PRIMARY Proportion of Persons Completing All Scheduled Visits in Each Study Arm |
0.44; 0.44; 0.37 | — |
| PRIMARY Number of Adverse Events |
0.78; 1.3; 1.3 | — |
| SECONDARY Unprotected Sex Acts in Previous One Week - 12 Weeks |
0; 0.5; 1.2 | — |
| SECONDARY Unprotected Sex Acts in Previous One Week - 26 Weeks |
0.25; 0.1; 0.5 | — |
| SECONDARY Unprotected Sex Acts in Previous One Week - 52 Weeks |
0.8; 0.2; 0 | — |
| SECONDARY Unprotected Sex Acts in Previous One Month - 12 Weeks |
0; 0.8; 0 | — |
| SECONDARY Unprotected Sex Acts in Previous One Month - 26 Weeks |
0.25; 0.2; 0.4 | — |
| SECONDARY Unprotected Sex Acts in Previous One Month - 52 Weeks |
0.8; 0.5; 0 | — |
| SECONDARY Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) |
0.14; 0.42; 0.15 | — |
| SECONDARY Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) |
0.14; 0.42; 0.15 | — |
| SECONDARY Cumulative Incidence Herpes Simplex Virus Type 2 |
0.5; 1.0; 0.3 | — |
| SECONDARY Cumulative Incidence Herpes Simplex Virus Type 2 |
0.5; 1.0; 0.3 | — |
| SECONDARY Number of Partners Reporting for HIV Testing |
0.4; 0.4; 0.4 | — |
| SECONDARY Proportion of Partners Reporting for HIV Testing |
0.1; 0.1; 0.1 | — |
| SECONDARY Suppression of HIV RNA to <1000c/ml at 12 Weeks |
0.5; 0.25; 0.72 | — |
| SECONDARY Time to HIV RNA Suppression <1000 c/ml |
39; 26; 16 | — |
| SECONDARY Blood HIV RNA Concentration at Week 12 |
19411; 22734; 20 | — |
| SECONDARY Blood HIV RNA Concentration at Week 26 |
8661; 58504; 6788 | — |
| SECONDARY Blood HIV RNA Concentration at Week 52 |
3248.5; 6467.5; 10876 | — |
| SECONDARY Genital HIV RNA Concentration - Week 12, Women |
82.5; 0; 38.5 | — |
| SECONDARY Genital HIV RNA Concentration - Week 26, Women |
11.5; 0; 164 | — |
| SECONDARY Genital HIV RNA Concentration - Week 52, Women |
0; 219; 2111 | — |
| SECONDARY Genital HIV RNA Concentration - Week 12, Men |
25364; 446; 0 | — |
| SECONDARY Genital HIV RNA Concentration - Week 26, Men |
9456; 292; 0 | — |
| SECONDARY Genital HIV RNA Concentration - Week 52, Men |
13088; 66; 0 | — |
Summary
Eligibility Criteria
Inclusion Criteria
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 Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01450189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.