Status:
COMPLETED
Succinylated Human Serum Albumin (Suc-HSA) for HIV-1 Infection
Lead Sponsor:
International Antiviral Therapy Evaluation Center
Collaborating Sponsors:
University Medical Center Groningen
Prothya Biosolutions
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of the study is to evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily intravenous (i.v.) doses. The secondary objectives are to evaluate the safety and tole...
Detailed Description
This is a single centre, single arm study. Subjects will receive 5 consecutive daily doses of Suc-HSA at a dose of 10 mg/kg on days 0, 1, 2, 3 and 4 on the Special Investigation Unit (SIU), with a saf...
Eligibility Criteria
Inclusion
- Patient is ≥ 18 years of age;
- Voluntarily signed informed consent;
- Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA);
- Patient is HIV-1 treatment naïve;
- CD4+ T-cell count ≥ 350 x 10\^6/L;
- Plasma HIV-1 RNA level at screening visit of at least 5.000 copies/ml, and not varying more than ± 0.5 log10 copies during the preceding 6 month period;
- Patient was participant in part 1 of the original Suc-HSA study (protocol no. 2003-002, version 2.4, dated 18 November 2003) and the administration of Suc-HSA occurred more than 8 weeks ago, OR patient was not participant in this study;
- Patient is one of the following:
- not heterosexually active, OR
- a heterosexually active female, agreeing to use an effective method of contraception with her partner (combined oral contraceptive pill; injectable contraceptive; intrauterine contraceptive device (IUCD); consistent use of condoms if using these; physiological or anatomical sterility in herself or her partner) from 14 days prior to the first administration of study medication until 4 months after the last, and willing to undergo urine pregnancy tests prior to the first and last administration, OR
- a heterosexually active male, agreeing to use an effective method of contraception with his partner from the day of the first administration until 4 months after the last administration.
Exclusion
- History of an AIDS defining event;
- Use of antiretroviral or immunomodulatory therapy;
- Any reason to start antiretroviral therapy at the time of enrolment or which is expected to occur during the course of the study at the time of enrolment;
- Presence of active, replicating hepatitis B and/or C virus co-infection;
- ASAT and/or ALAT \> 3 times upper limit of normal (ULN) (AIDS Clinical Trials Group \[ACTG\] toxicity scale);
- Serum creatinine measuring \> 1.5 x ULN;
- Total bilirubin \> 2x ULN;
- Neutropenia (absolute neutrophil count \< 1000/mm3);
- Presence of any clinically significant disease or findings during screening, that in the opinion of the investigator could compromise the safety of the subject;
- Patient is female and (willing to become) pregnant or breast-feeding;
- Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00128063
Start Date
August 1 2005
End Date
June 1 2006
Last Update
April 24 2007
Active Locations (1)
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1
Academic Medical Center, University of Amsterdam
Amsterdam, North Holland, Netherlands, 1105AZ