HIV InfectionsPhase 2NCT00951743
Safety and Efficacy of ADAPTAVIR's Ability to Eliminate Treatment-Resistant Infectious Virus in Peripheral Blood Mononuclear Cells (PBMCs)
A Phase 2 study testing Adaptavir (monomeric DAPTA) in people with HIV Infections, run by Rapid Laboratories Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Adaptavir (monomeric DAPTA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
Richard Elion, MD
About this study
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.
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.
Read the detailed 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.
- Conditions
- HIV Infections
- Being tested
- Adaptavir (monomeric DAPTA)
- Keywords
- AIDS, HIV, mDAPTA
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptavir (monomeric DAPTA)Drug
Also called Adaptavir, Monomeric DAPTA, DAPTA -D ala Peptide T
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Adaptavir (monomeric DAPTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months with 2 month follow up
Secondary outcomes (1)
Virological and Immunological outcome measures
Measured: 6 months with 2 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rapid Laboratories Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Richard Elion, MD, Principal investigator, Whitman Walker clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951743
- Sponsor's protocol ID
- RAPID Laboratories 001
- Status last verified
- Aug 2009
- First submitted
- 31 Jul 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00951743
- Acronym / sponsor ID
- RAPID Laboratories 001
- Conditions
- HIV Infections
- Keywords
- AIDS, HIV, mDAPTA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rapid Laboratories Inc.University, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptavir Treatment | Experimental | Drug: Adaptavir (monomeric DAPTA)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 | Placebo comparator | Drug: Adaptavir (monomeric DAPTA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptavir (monomeric DAPTA)Also: Adaptavir, Monomeric DAPTA, DAPTA -D ala Peptide TIntranasal (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. | Drug | Adaptavir Treatment, Placebo |
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
1 secondary outcome
Virological and Immunological outcome measures
Time frame: 6 months with 2 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Elion, MD principal investigator
Whitman Walker clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adaptavir (monomeric DAPTA) in people with HIV Infections, run by Rapid Laboratories Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Elion, MD (202-745-6152, rickelion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009.