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

What Was Tested

In this phase 2 trial, researchers set out to test Peptide T.

The main (intent to treat) analysis is planned for the 24 week endpoint.

It had two arms (groups): Adaptavir Treatment (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: HIV positive, male or female of any race and at least 18 years of age. Must have received continuous currently acceptable anti-retroviral therapy ("HAART"; highly active antiviral therapy) for at least six months prior to entry. Must have HIV-1 plasma viral load RNA (PCR or bDNA) \< 200 copies/mL for 90 days prior to randomization in this study. Must have a sustained CD4+ cell count \> 350 cells/mm3 for 90 days prior to randomization in this study. Must be considered clinically stable, in the opinion of the investigator, at the time of entry into the study.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: expected to require adjustment to their antiretroviral therapy during screening or within 8 weeks after initiating mdapta therapy; current participation in other clinical trials with investigational drugs; use of any investigational agents including immunomodulatory agents (gm csf, interferon, interleukin etc.) within 60 days prior to study entry.

How the Study Was Run

The set-up was randomized, factorial and quadruple-blind.

The participants were allocated by chance, so the Peptide T group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Peptide T.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-07 with completion listed for 2010-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To assess the safety & toxicity of mDAPTA in HIV infected individuals with suppressed viral loads on HAART treatment & assess the proportion of study participants achieving PMBC viral culture negative status at 24weeks (time frame: 6 months with 2 month follow up).

It also tracked 1 secondary outcome, for example Virological and Immunological outcome measures.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Peptide T in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Peptide T compound page, all human trials.