{"id":5404,"date":"2023-04-21T12:17:06","date_gmt":"2023-04-21T19:17:06","guid":{"rendered":"https:\/\/www.iths.org\/participate\/?p=5404"},"modified":"2023-04-21T12:17:06","modified_gmt":"2023-04-21T19:17:06","slug":"first-in-human","status":"publish","type":"post","link":"https:\/\/www.iths.org\/participate\/first-in-human\/","title":{"rendered":"First in Human"},"content":{"rendered":"
<\/div>\n

First in human clinical trial of a next generation, long-acting injectable, combination anti-retroviral therapy platform. This study will look at drug levels in the blood over time and the safety of a single injection of a new investigational medicine that combines existing short-acting oral drugs to treat HIV. The length of the study is approximately 2 months. There is a single under the skin injection of a combination of low doses of lopinavir, ritonavir, and tenofovir. Reimbursement will range from $440-$1240, depending on your chosen level of participation. Additional $150 for lymph node biopsies. Call\/text UW Positive Research at 206-773-7129.<\/p>\n

Participant Eligibility<\/h3>\n

Healthy adults between the ages of 18-65<\/p>\n

All genders<\/p>\n

HIV Negative<\/p>\n

No active hepatitis B<\/p>\n

No active hepatitis C<\/p>\n

Non-smokers or former smokers (quit >1 year ago)<\/p>\n

Low risk for HIV infection<\/p>\n

Not taking ANY prescription or over the counter medications (that cannot be safely stopped)<\/p>\n

No active drug or alcohol abuse<\/p>\n

If use cannabis, willing to stop cannabis use for 2 weeks before and during study<\/p>\n

Body size (weight for height) normal or overweight (BMI 18.5-29.9)<\/p>\n

Women of non-child-bearing potential
\n(Either no sex with men, or post-menopause or copper IUD or hysterectomy or tubal ligation or ovaries removed. Hormones of any type are exclusions.)<\/p>\n

Persons of child-bearing potential must use 2 of the following types of contraceptives throughout the study: Condom (male or female), Diaphragm or cervical cap with spermicide, Copper-based intrauterine device, Vasectomy in the male partner<\/p>\n

No tattoos on abdomen near the belly-button<\/p>\n

Contact<\/h3>\n

Eli Burnham, PA-C
\n(206) 773-7129<\/p>\n

<\/p>\n

Additional Study Details<\/h3>\n

Full Study Title<\/strong>
\n0 First in human clinical trial of a next generation, long-acting injectable, combination antiretroviral therapy platform Phase I Study
\n<\/span><\/p>\n

Study ID:<\/strong> 00007490<\/div>\n
ClinicalTrials.gov Link:<\/strong><\/div>\n
<\/div>\n
Start Date:<\/strong> 04\/04\/2023<\/div>\n
End Date:<\/strong> 04\/30\/2024<\/div>\n
<\/div>\n

Investigator(s)<\/strong>
\nRachel Bender-Ignacio, MD
\n<\/span>
\nAccepts Healthy Volunteers?<\/strong>
\nYes<\/span><\/p>\n

Study Site(s)<\/strong><\/p>\n

\n

UW Positive Research<\/h4>\n

325 9th Ave
\nSeattle, Washington 98104<\/p>\n<\/div>\n

\n

<\/h4>\n<\/div>\n
<\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

First in human clinical trial of a next generation, long-acting injectable, combination anti-retroviral therapy platform. This study will look at drug levels in the blood over time and the safety of a single injection of a new investigational medicine that combines existing short-acting oral drugs…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,14],"tags":[1455,1444,1375,1451,1450,1447,1448,98,258,1445,1446,1449,1452,1453,1454],"class_list":["post-5404","post","type-post","status-publish","format-standard","hentry","category-healthy-volunteers","category-allergies-immune-system","tag-all-genders","tag-allergy-and-immune","tag-antiretroviral","tag-art","tag-arvs","tag-first-in-human","tag-first-in-humans","tag-healthy-volunteers","tag-hiv","tag-hiv-negative","tag-hiv-studies","tag-long-acting-injectable","tag-next-generation","tag-university-of-washington","tag-uw-positive-research"],"_links":{"self":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5404","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/comments?post=5404"}],"version-history":[{"count":3,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5404\/revisions"}],"predecessor-version":[{"id":5407,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5404\/revisions\/5407"}],"wp:attachment":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/media?parent=5404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/categories?post=5404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/tags?post=5404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}