Overview

This trial is active, not recruiting.

Condition hiv-infection
Treatments vm-1500, efavirenz, antiretroviral therapy (art)
Phase phase 2/phase 3
Sponsor Viriom
Start date August 2014
End date December 2016
Trial size 150 participants
Trial identifier NCT02489461, HIV-VM1500-04

Summary

To evaluate the following safety and efficacy parameters for VM-1500:

- Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 12 (Stage I)

- Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 24 (Stage II)

- Decrease in viral load during 48 weeks of treatment

- Percentage of subjects with at least 10-fold (1 log10) decrease in viral load at Week 4

- Percentage of subjects with decrease in viral load to <400 copies/ml at Week 12

- Percentage of subjects who continued to receive the investigational treatment up to Week 48

- СD4+ and СD8+ cell count change during 48 weeks of the study

- Percentage of subject who developed HIV-1 resistance to the investigational treatment by week 48

- Frequency of adverse events (AE) of different severity according to subjective complaints, physical assessment, vital signs, laboratory tests, ECG

- Frequency of adverse events of special interest, including of central nervous system (CNS) effects

- VM-1500 pharmacokinetic profile in selected subjects

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
VM-1500 20 mg
vm-1500
VM-1500 up to 48 weeks
antiretroviral therapy (art)
ART up to 48 weeks
(Experimental)
VM-1500 40 mg
vm-1500
VM-1500 up to 48 weeks
antiretroviral therapy (art)
ART up to 48 weeks
(Active Comparator)
Efavirenz 600 mg
efavirenz Stocrin®
Efavirenz up to 48 weeks
antiretroviral therapy (art)
ART up to 48 weeks
(Experimental)
VM-1500 (optimal dose)
vm-1500
VM-1500 up to 48 weeks
antiretroviral therapy (art)
ART up to 48 weeks

Primary Outcomes

Measure
Optimal dose selection for VM-1500 in combination with two nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) based on analysis of AEs, laboratory values, subjects' diaries.
time frame: 48 weeks
Efficacy evaluation of VM-1500 (optimal dose selected at Stage I) in combination with two NRTIs, as compared to Efavirenz in combination with two NRTIs based on analysis of viral load.
time frame: 52 weeks
Safety evaluation of VM-1500 (optimal dose selected at Stage I) in combination with two NRTIs, as compared to Efavirenz in combination with two NRTIs based on analysis of AEs, laboratory values and subjects' diaries.
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Signed Patient Information and Informed Consent Form. 2. Males and females, age ≥ 18 years. 3. HIV-1 infection, confirmed serologically in IFA or immunoblot analysis (or documented HIV-1 infection). 4. Clinically stable HIV infection (clinical stages 1 or 2 according to the WHO classification). 5. Indications (in the Investigator's opinion) for ART, according to the WHO Summary Guideline for use of antiretroviral drugs in HIV prevention and treatment (2013). 6. HIV-1 RNA plasma level ≥ 5 000 copies/ml at screening. 7. СD4+ Т-cells number > 200 cells/mm3 at screening. 8. Laboratory parameters as follows: White blood cells ≥ 2900/mm3 (2,9 x 109 cells/l) Absolute neutrophils ≥ 1500/mm3 (1,5 x 109 cells/l) Platelets ≥ 100000/mm3 (100 x 109 cells/l) Hemoglobin ≥ 9.0 g/dl Total bilirubin ≤ 1.5 x ULN AST and ALT≤ 2.5 x ULN Renal function GFR > 60 ml/min Exclusion Criteria: 1. Primary HIV-1 resistance to ART. Viral resistance mutations are defined as any basic mutations of resistance to NNRTIs, according to the updated list of VIH-1 resistance mutations (International AIDS society, 2013), associated with drug resistance in any genotype. 2. History of antiretroviral therapy (ART), including for the prevention of vertical transmission of HIV. 3. Acute hepatitis or hepatic cirrhosis of any etiology; anti-HCV antibodies or HBsAg at screening. 4. Signs of acute infection or positive test result for syphilis, hepatitis A, Toxoplasma gondii, cytomegalovirus, gonorrhea, Chlamydia trachomatis during 30 days before screening. 5. Opportunistic infections of the Category C (Centers of Disease Control (CDC), 2008), excluding Kaposi's sarcoma not requiring systemic therapy. 6. History of tuberculosis of any localization, or tuberculosis at screening, according to x-ray examination. 7. History of malignant tumors (except basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ, eliminated and cured ≥ 5 years ago).

Additional Information

Official title International, Multicenter, Randomized, Partially Blind Clinical Study to Evaluate Efficacy, Safety and Selection of the Optimal Dose for VM-1500 in Comparison to Efavirenz in Combination With Two NRTIs in Treatment-naïve, HIV-1 Infected Patients
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Viriom.