Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
Source: ClinicalTrials.gov NCT02165202 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase |
59; 31 | — |
Eligibility Criteria
Inclusion Criteria: Women who meet all of the following criteria will be eligible for inclusion in the study:
- Women, 18- 45 years (inclusive) of age at Enrollment
- Female at birth
- Willing and able to provide informed consent to take part in the study
- Willing and able to provide adequate locator information
- Willing and able to provide acceptability and adherence assessments throughout the study
- Understands and agrees to local reporting requirements for sexually transmitted infections (STis)
- No evidence of an active STI, women who have an STI (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), or syphilis) identified at the Screening visit are ineligible*
- Per participant report, no diagnosis of GC, CT, or syphilis in the last 6 months
- Availability to return for all study visits and participate in all study-related procedures, barring unforeseen circumstances
- Per participant report, using (or willing to use) an acceptable form of contraception (e.g., intrauterine device [IUD], hormonal contraception [DMPA], oral, injectable, transdermal patch, implants) from screening until one month after last study visit or surgical sterilization of the participant
- Must agree to use condoms for the duration of the study
- Must agree not to participate in other concurrent drug or vaccine trials
- Normal laboratory values**
(HIV tests performed at Screening and Enrollment are non- reactive/negative (see Study Specific Procedures (SSP) Manual)
- Hemoglobin (women) =:: 10.5 g/dL
- Absolute neutrophil count1,000 cells/mm 3
- Platelet count=:: 100,000/mm3
- Calculated creatinine clearance =: : 70 mL!minute using the Cockcroft-Gault equation
- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) 450 ms
- QRS interval 120 ms
- PR interval> 210 ms
- History of additional risk factors for Torsade de Pointes (TdP), such as heart failure, hypokalemia, hypomagnesia, family history of known long QT syndrome, or sudden death at young age (S 40 years) in a first-degree relative (i.e., biological parent, sibling, or offspring)
- Currently active Tuberculosis (TB), or undergoing treatment for the same (by self-report)
- Any signs or symptoms consistent with acute (pre-seroconversion) HIV infection, or self-reported concern about recent HIV infection
- Any reactive or positive HIV test at Screening or Enrollment, even if the person is confirmed to be HIV-uninfected
- Has any other condition that, in the opinion of the site loR or designee, would preclude informed consent, make study participation unsafe, interfere with adherence, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives (e.g., at increased risk of cardiovascular vents)
Women who do not meet eligibility criteria because of an abnormal EKG, risk factors for TdP, an STI (GC, CT, or syphilis) present at Screening or report of an STI (GC, CT, or syphilis) in the past 6 months, or a history of arrhythmia may not be re-screened.
Women who present at Screening with symptoms consistent with an acute HIV infection or who have a reactive HIV test may not be re-screened. Women who do not meet eligibility criteria for the study for other reason(s) may be re-screened at a future date at the discretion of the site loR.
3.2.1 Exclusion Criteria for the Tissue Subset (US sites only)
Participants of the Tissue Subset must meet the above eligibility criteria to be enrolled in HPTN 076. Participants interested in participating in the Tissue Subset must meet additional inclusion and exclusion criteria. Women who meet any of the following criteria will be excluded from the Tissue Subset:
- Unwillingness to abstain from the following medications for a period of 10 days before a biopsy procedure:
- Aspirin*
- Non-steroidal anti-inflammatory drugs (NSAIDS)
*Daily use of low-dose aspirin (no more than 81 mg) is allowed at the discretion of the loR.
- Unwillingness to abstain from the following medications for 3 days prior to vag
Data sourced from ClinicalTrials.gov (NCT02165202). 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. Informational only — not medical advice.