Phase 2
Completed N=199
Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
Source: ClinicalTrials.gov NCT02178800 ↗Enrolled (actual)
199
Serious AEs
3.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only) — 121; 38 Participants
Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only) |
121; 38 | — |
| PRIMARY Number of Participants Who Discontinue Injectable Study Product for Reasons of Toxicity, Tolerability, or Acceptability That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only) |
11; 2 | — |
| PRIMARY Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744) |
1.32; 2.40; 1.29; 2.28; 1.49; 1.77 | — |
| SECONDARY Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities During Tail Phase |
107; 18 | — |
| SECONDARY Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Prior to Completion of the Oral Phase |
84; 25 | — |
| SECONDARY Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future |
80; 74; 74; 81; 73; 71 | — |
| SECONDARY Number of Participants With HIV Infections Through the Study Period, Stratified by Arm |
1; 0 | — |
| SECONDARY Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period |
0.81; 0.92; 0.84; 0.78; 0.81; 0.84 | — |
| SECONDARY Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Oral Phase |
17; 7 | — |
| SECONDARY Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Injection Phase |
29; 12 | — |
| SECONDARY Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Oral Phase |
0; 0 | — |
| SECONDARY Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Injection Phase |
3; 0 | — |
| SECONDARY Number of Participants Who Discontinue Oral Study Product for Reasons of Toxicity, Tolerability, or Acceptability Prior to Completion of the Oral Phase |
6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women, 18 to 65 years old at the time of screening
- Willing to provide informed consent for the study
- In the last 12 months (at the time of screening):
- No self-reported unprotected anal or vaginal intercourse with someone known to be HIV-infected or of unknown HIV infection status
- No self-reported stimulant use (cocaine [including crack], methamphetamine, or non-physician-prescribed pharmaceutical-grade stimulants) or inhaled nitrate
- No self-reported illicit injection drug use of any kind
- No self-reported diagnosis of gonorrhea (GC), chlamydia (CT), incident syphilis, bacterial vaginosis, or trichomoniasis
- Not reporting five or more different sexual partners, regardless of use of protection or knowledge of HIV status. More information on this criterion is available in the protocol.
- In general good health, as evidenced by the following laboratory values, which must be from specimens obtained within 45 days prior to study enrollment:
- Non-reactive/negative HIV test results. More information on this criterion is available in the protocol.
- Hemoglobin greater than 11 g/dL
- Absolute neutrophil count greater than 750 cells/mm^3
- Platelet count greater than or equal to 100,000/mm^3
- Calculated creatinine clearance greater than or equal to 70 mL/minute using the Cockcroft-Gault equation
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to the upper limit of normal (ULN)
- Total bilirubin less than or equal to Grade 1 and direct bilirubin less than or equal to ULN
- Hepatitis B surface antigen (HBsAg) negative
- Hepatitis C Ab negative
- Note: Chemistry and hematology parameters which do not meet the inclusion criteria above may be repeated once during screening.
- No alcohol or substance use that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records). More information on this criterion is available in the protocol.
- No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
- Willing to undergo all required study procedures
Additional requirements for all women:
- If of reproductive potential (defined as pre-menopausal women who have not had a sterilization procedure per self-report, such as hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy), must have a negative urine pregnancy test performed (and results known) within 48 hours before initiating the protocol-specified medication(s) at enrollment. Women are considered menopausal if they have not had a menses for at least 12 months and have a follicle stimulating hormone (FSH) level of greater than 40 IU/L; if FSH testing is not available, they must have had amenorrhea for 24 or more consecutive months. (FSH testing is not a protocol requirement.)
- If of reproductive potential and participating in sexual activity that could lead to pregnancy, women must agree to use a form of contraception during the trial and for 30 days after stopping the oral study medication or for 52 weeks after stopping the long acting injectable from the list below:
- Intrauterine device (IUD) or intrauterine system (IUS) that meets less than 1% failure rate as stated in the product label
- Hormone-based contraceptive
Exclusion Criteria
- One or more reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed
- Any active sexually transmitted infection detected by laboratory testing at Screening
- Co-enrollment in any other HIV interventional research study or other concurrent studies which may interfere with this study (as provided by self-report or other available documentation; exceptions may be made if appropriate after consultation with th
Data sourced from ClinicalTrials.gov (NCT02178800). 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.