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

HIV Infections Clinical Trial

Official title:

A Phase 1 & 2, Randomized Open-Label Study to Evaluate the Pharmacokinetics, Safety and Antiretroviral Activity of Succinylated Human Serum Albumin (Suc-HSA) in Treatment Naïve HIV-1 Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128063
• Other study ID #: 04-IAT-0047
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 8, 2005
• Last updated: April 23, 2007
• Start date: August 2005
• Est. completion date: June 2006

Study information

• Verified date: April 2007
• Source: International Antiviral Therapy Evaluation Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• succinylated human serum albumin

Locations

Country	Name	City	State
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam	NH

Sponsors (3)

Lead Sponsor	Collaborator
International Antiviral Therapy Evaluation Center	Sanquin, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily i.v. doses.
Secondary	To evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA.

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