Succinylated Human Serum Albumin (Suc-HSA) for HIV-1 Infection

NCT ID: NCT00128063

Last Updated: 2007-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-06-30

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 tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA.

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 safety follow up on the SIU for 4 hours on day 1 and 2 hours on the next days. There will be follow-up visits on week 1, 2, 4 and 12. Standard safety parameters (physical examination, clinical symptoms, laboratory hematology and biochemistry) will be followed until week 12. Plasma HIV-1 RNA and CD4+/CD8+ cell counts will be assessed at every visit. Plasma drug levels (trough and peak) will be measured from baseline until week 2.

6 patients will be included in this study as described in this protocol amendment.

Eligible subjects are chronic HIV-1 infected patients who have never been treated with antiretroviral treatment and for whom there is no need to start antiretroviral treatment.

Test Product: Suc-HSA, a candidate HIV-1 fusion inhibitor.

Duration of treatment: 5 days

Criteria for evaluation:

• Safety: symptoms, signs at physical examination, standard hematology and chemistry laboratory parameters- Efficacy: changes in plasma HIV-1 RNA and CD4+ T cell count
• Pharmacokinetics: plasma levels of Suc-HSA: Cmin, Cmax and AUC

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

succinylated human serum albumin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient is ≥ 18 years of age;

2. Voluntarily signed informed consent;

3. Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA);

4. Patient is HIV-1 treatment naïve;

5. CD4+ T-cell count ≥ 350 x 10^6/L;

6. 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;

7. 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;

8. 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 Criteria

1. History of an AIDS defining event;

2. Use of antiretroviral or immunomodulatory therapy;

3. 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;

4. Presence of active, replicating hepatitis B and/or C virus co-infection;

5. ASAT and/or ALAT > 3 times upper limit of normal (ULN) (AIDS Clinical Trials Group [ACTG] toxicity scale);

6. Serum creatinine measuring > 1.5 x ULN;

7. Total bilirubin > 2x ULN;

8. Neutropenia (absolute neutrophil count < 1000/mm3);

9. Presence of any clinically significant disease or findings during screening, that in the opinion of the investigator could compromise the safety of the subject;

10. Patient is female and (willing to become) pregnant or breast-feeding;

11. Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Prothya Biosolutions

INDUSTRY

Sponsor Role: collaborator

International Antiviral Therapy Evaluation Center

OTHER

Sponsor Role: lead

Principal Investigators

Joep MA Lange, MD PhD

Role: STUDY_CHAIR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Jan Prins, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Academic Medical Center, University of Amsterdam

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Related Links

http://www.iatec.com

Related Info

Other Identifiers

04-IAT-0047

Identifier Type: -

Identifier Source: org_study_id