Safety and Efficacy of ADAPTAVIR's Ability to Eliminate Treatment-Resistant Infectious Virus in Peripheral Blood Mononuclear Cells (PBMCs)

HIV Infections Clinical Trial

Official title: Safety and Efficacy of ADAPTAVIR's Ability to Eliminate Treatment-Resistant Infectious Virus in the Blood Cellular Reservoir (PBMCs) of HIV Patients With Suppressed Plasma Viral Load.

Status Recruiting

Clinical Trial Summary

This is a 24 week placebo controlled, double-blind, 2-arm study of ADAPTAVIR, Monomeric Dala1-peptide T-amide (mDAPTA) compared to placebo, in HIV infected individuals with suppressed plasma viral loads < 200 copies/ml by highly active antiretroviral therapy (HAART) treatment for at least 3 months prior to entry with at least 6 continuous months of HAART treatment preceding entry. 20 treatment and 20 placebo individuals will be enrolled in each arm. The study duration is 24 weeks on placebo or mDAPTA administered intranasally at 0.01 mg two times a day.

The main (intent to treat) analysis is planned for the 24 week endpoint. The virological outcomes of interest in the present study are infectious virus recoverable from cellular (PBMC) sources and cellular viral mRNA and DNA copy numbers. Immune outcomes (plasma cytokines) associated with HIV disease, HIV replication, or immune function will be studied.

Clinical Trial Description

A primary objective of this study is to assess the safety and toxicity of mDAPTA (Adaptavir) in HIV infected individuals with suppressed viral loads with HAART treatment and assess the proportion of study participants achieving PMBC viral culture negative status at 24weeks. PMBC viral culture status is a direct measurement of treatment resistant, residual, active HIV replication in the peripheral blood mononuclear cells. We hypothesize this proportion will be significantly greater in the treatment arm relative to the placebo arm (the odds of achieving this endpoint are significantly greater in mDAPTA- than in placebo-treated participants).

Secondary Endpoints (all analyzed as odds ratios) are to determine

• The proportion of study participants achieving (0.5 log10) decrease in quantitative viral mRNA in PBMCs will be significantly greater in the treatment arm relative to the placebo arm.

• The proportion of study participants achieving (0.5 log10) decrease in quantitative viral DNA in PBMCs will be significantly greater in the treatment arm relative to the placebo arm.

• The proportion of study participants whose plasma viral loads were greater than 200 copies/ml on two successive measurements 6 weeks apart will be significantly greater in the placebo arm relative to the treatment arm.

Immunological outcome hypotheses, based on 24-week data

• The proportion of study participants achieving at least greater than 50% decrease in the inflammatory cytokines TNFa, IL-10, IL-8 or IL-6 will be significantly greater in the treatment arm relative to the placebo arm.

• The proportion of study participants achieving at least greater than 50% increase in the cytokines IL-2, IL-10, IL-12, IL-13 and IFNa will be significantly greater in the treatment arm relative to the placebo arm.

• The proportion of study participants achieving at least an increase in CD4 T cells will be significantly greater in the treatment arm relative to the placebo arm.

• The proportion of study participants whose viral load becomes greater than 200 copies/ml will be significantly greater in the placebo arm relative to the treatment arm. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT00951743
• Study type: Interventional
• Source: Rapid Laboratories Inc.
• Contact: Richard Elion, MD
• Phone: 202-745-6152
• Email: rickelion@gmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2009
• Completion date: July 2010