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

NCT00951743 | Unknown Phase 2

• 1 other identifier: RAPID Laboratories 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

AIDS; HIV; mDAPTA

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months with 2 month follow up

Secondary Outcomes (1)

• Virological and Immunological outcome measures

  6 months with 2 month follow up

Study Arms (2)

Adaptavir Treatment

EXPERIMENTAL

MDAPTA (Adaptavir) will be administered intranasally at 0.01 mg twice per day. Individuals with plasma viral load (PCR Roche Amplicor Ultrasensitive assay) less than 200 copies/mL, sustained for the previous 90 days, with CD4\>350 cells/mm3 will be eligible to participate.

Drug: Adaptavir (monomeric DAPTA)

Placebo

PLACEBO COMPARATOR

Placebo will be administered intranasally at 0.01 mg twice per day. Individuals with plasma viral load (PCR Roche Amplicor Ultrasensitive assay) less than 200 copies/mL, sustained for the previous 90 days, with CD4\>350 cells/mm3 will be eligible to participate.

Drug: Adaptavir (monomeric DAPTA)

Interventions

Adaptavir (monomeric DAPTA) DRUG

Intranasal (IN) Solution: 20 mL of solution in a 20 mL polyethylene screw top vial to which a metered sprayer is adapted. Each spray releases approximately 0.1 0.12 mL. Available strength - 0.01mg/mI (active study medication), or no mDAPTA (placebo study medication), in water containing 0.25% benzyl alcohol as preservative and 250 mM mannitol (GRAS) to achieve isotonicity. Individuals in this study will be randomized to receive mDAPTA or placebo and be instructed to administer four metered nasal spray applications two times a day, in the morning, and in the evening, as close to 12 hours after the morning dose as practical. The planned daily dose of mDAPTA is 8 μg/day.

Also known as: Adaptavir, Monomeric DAPTA, DAPTA -D ala Peptide T

Adaptavir Treatment; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Women of childbearing potential must have a negative pregnancy test at screening prior to randomization in this study. Upon randomization, these women must agree to use methods of birth control or abstinence to prevent pregnancy.
• 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.

You may not qualify if:

• 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.
• Use of any vaccine, including for Influenza (killed or live), Pneumovax etc., within 60 days of initiating therapy with mDAPTA.
• Use or anticipated use of immunosuppressive therapy, including chemotherapy during participation in the study.
• Alcohol or substance abuse which, in the opinion of the investigator, would interfere with patient compliance or safety.
• Study participants with an active opportunistic infection or malignancy.
• Pregnant or breastfeeding.
• Any condition or history of any illness which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the participant.
• Participants who previously received treatment with DAPTA.

Sponsors & Collaborators

• Rapid Laboratories Inc.: lead

Study Sites (1)

Whitman Walker Clinic

Washington D.C., District of Columbia, 20009, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

D-Ala-peptide T-amide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Richard Elion, MD

  Whitman Walker clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Elion, MD

CONTACT

202-745-6152; rickelion@gmail.com

Tina Celenza, PA-C, MPH

CONTACT

(202) 745-6171; TCelenza@wwc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 11, 2009

Record last verified: 2009-08

Locations

US (1)