AcGM3/VSSP-aids-patients drug resistant to antiretroviral treatment-Phase I-II

Phase 1

Conditions: Acquired immunodeficiency syndrome (AIDS)
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases

Registration Number: RPCEC00000213

Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 25

Inclusion Criteria

1. Patients who have signed informed consent.
2. AIDS patients with antiretroviral treatment and evidence of multidrug resistance or with CD4 counts below 200 cells / uL for more than 2 consecutive assessments in the last 6 months with controlled viral load (not detectable or with values below the range 1 000 copies).
3. Patients aged between 18 and 50 years (including both).
4. Patients with overall according to WHO between 0 and 1.
5. Patients who have functioning of organs and bone marrow as defined by the following parameters (a) Hematopoietic:
Hb>=100 g / L, Leukocytes>= 3 x 109 cells / L, granulocytes>= 1 x 109 cells / L, Platelets >= 150 x 109 cells / L; b) Liver (No more than five times the upper limit of normal (ULN) *), Bilirubin: 17 pmol / L (LSN *), ALAT: 40 U / L (LSN *)
ASAT: 40 U / L (LSN *), Alkaline Phosphatase: 279 U / L *, LDH within normal levels: 214 U / L (LSN); c) Renal: Serum creatinine<= 132 pmol / L)
6. Life expectancy of 6 months or more.

Exclusion Criteria

1.Patients who have previously received the investigational product .
2.Patients receiving other investigational product .
3.Patients with known hypersensitivity to any component of the formulation.
4.pregnant or lactating patients
5.Patients of childbearing age who are not using an appropriate method of contraception ( intrauterine devices, hormonal contraceptives , barrier methods or tubal ligation) . If male (vasectomy , condom use ) during treatment .
6.Patients with acute allergic conditions or history of severe allergic reactions.
7.Patients suffering from uncontrolled intercurrent illness including, but not limited to : active infections , symptomatic congestive heart failure, unstable angina , cardiac arrhythmia and psychiatric diseases involving the incompetence of the subject.
8.Patients with other malignant disease treated correctly in the previous 5 years , except in situ cancer.
9.Virus infection Hepatitis B or C.
10. Opportunistic at the time of inclusion in the study infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I<br>Optimal therapeutic dose (Level of dose in that they yield minor patients' number with new opportunistic diseases or deaths to the 12 months, once a minor toxicity was associated (adverse serious event, related to the formulation). Measuring time: 168, 336 days.<br>Phase II<br>Clinical response (Appearance of opportunistic bigger diseases or death in the period of treatment. The opportunistic diseases will be evaluated using the criteria of the Control Disease Center for AIDS patients of the United States). Measuring time: 168, 336 days.<br>Adverse serious events related to with the formulation (The adverse events will be evaluated using the World Health Organization toxicity criteria). Measuring time: 168, 336 days.<br>

Secondary Outcome Measures