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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02165202 |
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Date of registration:
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21/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
TMC278LA |
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Scientific title:
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HPTN 076 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre-Exposure Prophylaxis (PrEP) |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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136 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02165202 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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South Africa
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United States
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Zimbabwe
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Contacts
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Name:
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Jessica Justman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bronx-Lebanon Hospital Center Clinical Research Site |
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Name:
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Shobha Swaminathan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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New Jersey Medical School Clinical Research Site |
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Name:
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Zvavahera Michael Chirenje, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Spilhaus Clinical Research Site |
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Name:
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Linda-Gail Bekker, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Desmond Tutu HIV Centre |
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Key inclusion & exclusion criteria
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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) < 2 times the
upper limit of normal (ULN)
- Total bilirubin < 2.5 ULN
- Urine protein< 2+
- Women who have an STI identified at the Screening visit (CT, GC, or syphilis)
will be provided treatment but are ineligible. Women who report having CT, GC, or
syphilis in the last six months are ineligible.
- Specimens for Screening labs must be obtained within 28 days prior to study
Enrollment.
3.1.1 Inclusion Criteria for the Tissue Subset (US sites only) A subset of approximately 24
participants at US sites will participate in more intensive sampling of vaginal tissue
during Week 36 (preferred) or Week 44.
For these participants, the following additional criteria need to be met:
•Satisfactory Pap results in the 12 calendar months prior to biopsy consistent with Grade 0
according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to
the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004
(Clarification dated August 2009), or satisfactory evaluation with no treatment required of
Grade 1 or higher Pap result per American Society for Colposcopy and Cervical Pathology
(ASCCP) guidelines in the 12 calendar months prior to biopsy is required, as indicated.
If there is no documentation of satisfactory Pap results, and if indicated, the participant
should be offered to have the test performed by the site prior to enrollment in the Tissue
Subset. If Pap testing is indicated and participants decline, they are not eligible for the
Tissue Subset.
- In addition to documentation of satisfactory Pap results, women must have normal
laboratory results for coagulation tests to be eligible for the Tissue Subset.
Abnormal coagulation test results may indicate an increased risk of bleeding.
- Women have to be willing to abstain from vaginal intercourse and practices involving
insertion of anything in the vagina (drug, douche, penis, or sex toy) for 3 days prior
to vaginal biopsy and for 7 days post-biopsy, to minimize risk of HIV-1 infection and
bleeding complications after the procedure.
- Participants must not be pregnant at the time of vaginal sampling, based on pregnancy
test results from previous visits and on the result of urine pregnancy test performed
on the same day before the proposed vaginal sampling.
- Women undergoing biopsy must have received all prior injections of study product, in
accordance with the protocol, to be eligible for inclusion.
Exclusion Criteria: Women who meet any of the following criteria will be excluded from the
study:
- Experiencing early menopause using clinical criteria (amenorrhea greater than six
months in absence of pregnancy) or a prior report of an abnormal Follicle Stimulating
Hormone (FSH) test
- PrEP or post-exposure prophylaxis (PEP) for HIV exposure within 90 days prior to
Screening
- Pregnant or last pregnancy outcome 90 days or less prior to Screening
- Currently breastfeeding
- Intends to become pregnant during the period of study participation
- Experiencing uncontrolled depression or active suicidal ideation
- History of recurrent urticaria
- Any history of anaphylaxis or severe allergy resulting in angioedema
- Any serious acute, chronic, or progressive disease (e.g. known history of neoplasm,
cancer, insulin-dependent diabetes, cardiac disease, auto-immune disease), or with
signs of cardiac disease, renal failure, or severe malnutrition
- Any laboratory abnormalities that are Grade 2 or higher, according to the DAIDS
Toxicology tables (please see Section 6.1 for a list of Screening laboratory tests)
- Recreational injection drug use in the 52 weeks prior to screening
- Participating or plans to participate in another research study involving study drugs,
vaccines or medical devices
- Participated in another research study involving study drugs, vaccines or medical
devices within the four weeks prior to screening; may be longer than four weeks
depending on half-life of study drug
- Past participation in an HIV vaccine study
- Has plans to relocate and cannot attend the visits at the clinic
- Per participant report at Screening, current or anticipated ongoing use and/or
unwillingness to abstain from contraindicated medications or supplements (listed in
the SSP Manual)
- Abnormal resting EKG at screening including:
- Abnormal sinus rhythm (heart rate below 40 or above 100 beats per minute)
- QTcF interval> 450 ms
- QRS interval < 50 ms
- QRS interval > 120 ms
- PR interval> 210 ms
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Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus (HIV)
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Intervention(s)
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Drug: Placebo
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Drug: Rilpivirine
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Primary Outcome(s)
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Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase
[Time Frame: Up to 52 weeks]
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Secondary ID(s)
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UM1AI068619
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1015131
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HPTN 076
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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