Recruiting
Phase 2

ADAPTAVIR

Sponsor:

Rapid Laboratories Inc.

Code:

NCT00951743

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adaptavir (monomeric DAPTA)

Study Details

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

Study ID

NCT00951743

Start date

Jul, 2009

Status verified date

Aug, 2009

Completion date

Jul, 2010

Anticipated

Primary completion date

May, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. HIV positive, male or female of any race and at least 18 years of age.
2. Must have received continuous currently acceptable anti-retroviral therapy ("HAART"; highly active antiviral therapy) for at least six months prior to entry.
3. Must have HIV-1 plasma viral load RNA (PCR or bDNA) < 200 copies/mL for 90 days prior to randomization in this study.
4. 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.
5. Must have a sustained CD4+ cell count > 350 cells/mm3 for 90 days prior to randomization in this study.
6. Must be considered clinically stable, in the opinion of the investigator, at the time of entry into the study.

Exclusion Criteria:

1. Expected to require adjustment to their antiretroviral therapy during screening or within 8 weeks after initiating mDAPTA therapy.
2. Current participation in other clinical trials with investigational drugs.
3. Use of any investigational agents including immunomodulatory agents (GM CSF, interferon, interleukin etc.) within 60 days prior to study entry.
4. Use of any vaccine, including for Influenza (killed or live), Pneumovax etc., within 60 days of initiating therapy with mDAPTA.
5. Use or anticipated use of immunosuppressive therapy, including chemotherapy during participation in the study.
6. Alcohol or substance abuse which, in the opinion of the investigator, would interfere with patient compliance or safety.
7. Study participants with an active opportunistic infection or malignancy.
8. Pregnant or breastfeeding.
9. 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.
10. Participants who previously received treatment with DAPTA.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptavir Treatment

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.

placebo comparator: Placebo

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.

Interventions

Adaptavir (monomeric DAPTA)

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Richard Elion, MD

202-745-6152rickelion@gmail.com

Tina Celenza, PA-C, MPH

(202) 745-6171TCelenza@wwc.org

Locations

Whitman Walker Clinic

Recruiting

Washington, District of Columbia, United States, 20009

Principal Investigator:

Richard Elion, MD

More Information

Sponsor

Rapid Laboratories Inc.

Last update posted

Aug 11, 2009

Last verified

Aug, 2009

Keywords

  • AIDS
  • HIV
  • mDAPTA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rapid Laboratories Inc. on 2009-08-11.