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

NCT00128063 | Completed Phase 1 DMC

• 1 other identifier: 04-IAT-0047
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV-1; succinylated human serum albumin; Treatment Naive

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

succinylated human serum albumin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Antiviral Therapy Evaluation Center: lead
• University Medical Center Groningen: collaborator
• Prothya Biosolutions: collaborator

Study Sites (1)

Academic Medical Center, University of Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Joep MA Lange, MD PhD

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

  STUDY CHAIR

• Jan Prins, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 9, 2005
• Study Start: August 1, 2005
• Study Completion: June 1, 2006
• Last Updated: April 24, 2007

Record last verified: 2007-04

Locations

NL (1)