Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
University Medical Centre Groningen
Sanquin
Information provided by:
International Antiviral Therapy Evaluation Center
ClinicalTrials.gov Identifier:
NCT00128063
First received: August 8, 2005
Last updated: April 23, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: succinylated human serum albumin
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by International Antiviral Therapy Evaluation Center:

Primary Outcome Measures:
  • To evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily i.v. doses.

Secondary Outcome Measures:
  • To evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA.

Estimated Enrollment: 6
Study Start Date: August 2005
Study Completion Date: June 2006
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128063

Locations
Netherlands
Academic Medical Center, University of Amsterdam
Amsterdam, NH, Netherlands, 1105AZ
Sponsors and Collaborators
International Antiviral Therapy Evaluation Center
University Medical Centre Groningen
Sanquin
Investigators
Study Chair: Joep MA Lange, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Jan Prins, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00128063     History of Changes
Other Study ID Numbers: 04-IAT-0047
Study First Received: August 8, 2005
Last Updated: April 23, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by International Antiviral Therapy Evaluation Center:
HIV-1
succinylated human serum albumin
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014