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

Study Overview
=================
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

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

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: succinylated human serum albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: succinylated human serum albumin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily i.v. doses. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, succinylated human serum albumin, Treatment Naive