| Eligibility |
Inclusion Criteria:
1. Successful engraftment of AGT103-T with at least 30 days post-infusion safety
monitoring during the AGT-HC-168 Parent Study.
Note: Successful engraftment is defined as detectable levels of AGT103-T cells bearing
the AGT103 lentivirus vector.
2. HIV <50 copies of viral RNA/mL plasma on stable ART.
3. Continuation on the same ART regimen during the AGT-HC-168 Parent Study unless change
in treatment with ART regimen is medically indicated.
4. CD4 T cell count >400 cells/mm3.
5. Ability to understand the study and willingness to comply with study-required
procedures and visits.
6. Written informed consent signed and dated by the study participant.
7. A negative pregnancy test for females of childbearing potential. A female participant
is considered to be of childbearing potential if she is menstruating, has an intact
uterus and at least 1 ovary, and is less than 2 years postmenopausal.
8. Unless medically prescribed, a negative drug test for amphetamines; barbiturates;
benzodiazepines; cocaine; methadone (Dolophine®); opiates (codeine, morphine only);
phencyclidine (PCP); propoxyphene.
9. Female participants of childbearing potential and male participants who are sexually
active with a partner of childbearing potential must agree to use an adequate method
of contraception at screening and throughout trial participation.
10. Female and male participants who are sexually active with a partner must agree to
abstain from sexual activity or use an adequate method of protection (e.g., condoms)
at screening and throughout trial participation.
11. Agree to not receive immunosuppressive and/or investigational therapies during the
study.
Note: Prohibited immunosuppressive medications do not include corticosteroid nasal
spray or inhaler; topical corticosteroids for mild, uncomplicated dermatitis; or
oral/parenteral corticosteroids given for non-chronic conditions.
12. Has adequate organ function as indicated by the following laboratory values:
- Hematocrit =33% or hemoglobin =13 g/dL (males) and =12 g/dL (females)
- Platelet count =150,000/mm3
- Absolute neutrophil count =1,500/mm3
- Serum creatinine =1.3 times ULN or calculated creatinine clearance (for those
with creatinine >1.3 ULN) =60 mL/min
- Prothrombin Time or INR = 1.5 times ULN
- Total bilirubin <1.5 times the ULN range. If total bilirubin is elevated, direct
bilirubin must be < 2 times the ULN range, except in participants with Gilbert's
Syndrome who must have serum bilirubin <3.0 times ULN (NOTE: If participant is on
an atazanavir containing therapy then a direct bilirubin should be measured
instead of the total bilirubin and must be = 1.0 mg/dL. Also, asymptomatic
elevations due to ART medications are not exclusionary when, in the opinion of
the Investigator, the abnormalities are not attributable to intrinsic hepatic
disease.
- Amylase < 3.0 times ULN at the time of screening
- AST (SGOT) and ALT (SGPT): = 3.0 times ULN
Exclusion Criteria
1. Any Grade 3 or higher drug product-related AE in the AGT-HC-168 Parent Study
(participant may be enrolled once AE resolved).
2. Any change in health status that would exclude enrollment in the AGT-HC-168 Parent
Study.
3. Active viral hepatitis B or hepatitis C infection. A complete hepatitis B virus (HBV)
screen (B core antibody, HBV surface antibody, and HBV surface antigen testing) must
be completed. Viral load testing will be used in questionable cases, per the
discretion of the Investigator.
- The results for hepatitis B may be positive for surface antibodies against HBV
but must be negative for circulating HBV surface antigen to confirm the absence
of active infection.
- The results for hepatitis C virus (HCV) may be positive for antibodies against
HCV but must be negative for HCV viral RNA in blood to confirm the absence of
active infection.
4. History of or current cancer or malignancy, with the exception of successfully treated
basal cell carcinoma of the skin.
5. Current diagnosis of New York Heart Association Grade 3 or 4 congestive heart failure,
uncontrolled angina, or arrhythmias.
6. Any clinically significant renal, hepatic, or pulmonary disease.
7. Is being treated for culture-confirmed bacteremia or had culture-confirmed bacteremia
within 1 month prior to screening.
8. Has signs or symptoms of acute infectious disease.
9. Significant laboratory values and/or chronic medical condition that in the opinion of
the Principal Investigator could impact trial participation.
10. Currently pregnant or breast-feeding.
11. Unwilling to use acceptable methods of birth control from the time of study entry to 1
month after restart of ART if sexually active with opposite sex. The following are
acceptable methods of birth control: condoms (male or female) with or without a
spermicidal agent, intrauterine device, diaphragm or cervical cap with spermicide, or
hormonal-based contraception.
12. Active alcohol use or dependence that, in the opinion of the Investigator, would
interfere with adherence to study requirements.
13. Serious illness requiring systemic treatment and/or hospitalization within 30 days
prior to screening.
14. Subject is unwilling to agree to practice safe sex or share needles.
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