Phase 1 HIV and AIDS Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed HIV diagnosis, documented by at least one standard HIV test (such as a rapid test, antibody test, or antigen/antibody test) and confirmed by a second method (such as a Western blot, a different antibody test, or an HIV RNA test).
• People aged 18 to 65 years old.
• People who are able and willing to give written consent to participate.
• People who are able and willing to stay in contact with the trial site for the entire duration of the trial.
• People who are able and willing to provide contact and location information so the trial site can reach them.
• People who are able and willing to follow all study requirements for the full duration of the trial.
• People who have been on HIV treatment (ART) continuously for at least 24 months before screening, defined as not missing more than 9 days in a row in the last 3 months before screening.
• People who have not changed any of their HIV medications in the 30 days before screening.
• People whose current HIV treatment regimen meets specific requirements — either at least 3 HIV medications including certain types (integrase inhibitor, NNRTI, or boosted protease inhibitor), or 2 medications where at least one is a boosted protease inhibitor or integrase inhibitor (confirm with trial site for details on permitted regimens).
• People for whom the trial doctors can identify a backup HIV treatment option, in case the current regimen stops working during the study.
• People who are able and willing to either continue their HIV treatment throughout the study, or temporarily stop it for up to 8 weeks if assigned to a specific study group, under close medical supervision.
• People whose HIV viral load (the amount of HIV in the blood) has been below 50 copies/mL at two separate time points in the past 24 months, and has never been at or above 50 copies/mL on two tests in a row during that time.
• People who have had no HIV viral load reading at or above 200 copies/mL in the 6 months before screening.
• People whose CD4 cell count (an immune system measure) is at least 400 cells/mm³ at screening.
• People who test negative for Hepatitis C antibodies at screening — or, for sites in the United States only, people who test positive for Hepatitis C antibodies but have a negative Hepatitis C RNA test at screening.
• People who test negative for Hepatitis B surface antigen at screening.
• Women who could become pregnant must have a negative pregnancy blood test at screening. This applies to women who have had a period in the last 24 months or who have not had a hysterectomy, removal of both ovaries, or removal of both fallopian tubes.
• People who have a sexual partner who does not have HIV, or whose HIV status is unknown, must be willing to use condoms, abstain from sex, or ensure their partner is on HIV prevention medication (PrEP) during the relevant part of the study, until their viral load is below 200 copies/mL (applies to a specific study group).
• People who agree not to try to conceive a child (through any means, including sperm donation or IVF) during the study and for 6 months after their last dose of the study drug.
• People who are sexually active in ways that could lead to pregnancy must agree to use at least one reliable form of contraception consistently — such as condoms, a diaphragm with spermicide, an IUD, tubal ligation, or hormonal contraception — starting at least 21 days before the study begins and continuing for 6 months after their last dose of the study drug.
• People who agree not to join another study involving an unlicensed experimental drug during the trial period.
• People who are willing to delay certain live vaccines (such as chickenpox, MMR, yellow fever, oral polio, and Mpox vaccines) from 30 days before joining through Week 16 of the study.
• People who are willing to delay routine vaccines (including flu shots) from 14 days before joining through Week 16 of the study.
• People who agree not to donate blood during the study.
• People with Type 2 diabetes must have blood sugar levels within a certain range at screening (HbA1c below 8, or fasting blood glucose at or below 125 mg/dL) (confirm with trial site).
• People whose liver, kidney, and other organ function results fall within the ranges specified in the trial protocol (confirm with trial site).

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People with an untreated syphilis infection (a positive test result without clear records of having been treated).
• People currently being treated for Hepatitis C, or who received Hepatitis C treatment within the 6 months before enrolling.
• People who received a blood transfusion or blood-stimulating growth factors within 3 months before enrolling.
• People who started HIV treatment within 90 days of being diagnosed with acute (very recent) HIV infection.
• People currently taking certain HIV medications that may interfere with the study drugs — specifically maraviroc (Selzentry), enfuvirtide (T-20), fostemsavir (Rukobia), or ibalizumab (Trogarzo).
• People using long-acting injectable HIV treatment.
• People who have used certain immune-modifying, cell-stimulating, or blood-thinning medications within 90 days before enrolling — including chemotherapy, immune globulin, interferons, warfarin, or similar blood thinners (confirm with trial site for full list).
• People who plan to use immune-modifying treatments during the study.
• People who have used oral or whole-body steroid medications within 30 days before enrolling, or who are expected to need them during the study. Note: low-dose steroids, inhaled steroids, nasal sprays, skin creams, or joint injections may still be permitted in some cases (confirm with trial site).
• People taking certain heart-rhythm medications that carry a specific risk of a dangerous heart rhythm problem called torsade de pointes — a long list of named medications is specified in the trial protocol (confirm with trial site for the full list).
• People who have used valproic acid (a medication sometimes used for epilepsy or mood disorders) within the last 30 days. A 30-day break from this medication may allow participation (confirm with trial site).
• People who have used another experimental (investigational) treatment within 6 months before enrolling, with some exceptions for higher-phase HIV medication trials (confirm with trial site).
• People who have had a serious illness requiring treatment or hospitalisation, unless they have been clinically stable on treatment for at least 90 days before enrolling, in the opinion of the site doctor.
• People with any medical, mental health, substance use, or other condition that the trial doctor believes would interfere with safely following the study requirements.
• People who have had a cancer diagnosis within the last 3 years. Note: certain resolved non-melanoma skin cancers may be permitted if confirmed by a skin specialist at least 3 months before enrolling (confirm with trial site).
• People who have an immune system problem not caused by HIV.
• People who have consistently had high blood pressure — above 150/100 mmHg — in the 6 months before screening.
• People who have a specific type of heart rhythm abnormality called QT prolongation at a moderate or higher level, as measured at screening (confirm with trial site).
• People with a history of acute or ongoing inflammation of the pancreas (pancreatitis).
• People with a bleeding or clotting disorder that requires special medical precautions, or who are on long-term blood-thinning medication.
• People with a history of blood clots in the lungs (pulmonary embolism) or legs (deep vein thrombosis).
• People with a history of hereditary, acquired, or unexplained swelling episodes called angioedema.
• People with a known allergy or sensitivity to the study drug ingredients.
• People with unstable asthma (including sudden attacks without a clear trigger), asthma that requires daily steroid or long-acting inhaler medication, or asthma that led to hospitalisation in the last two years.
• People with ongoing skin conditions such as eczema or psoriasis that are not controlled with topical (skin) treatments.
• People who are unable to communicate effectively with study staff.

Important: Always verify eligibility with the trial site directly before applying.