Drugs

Monomeric DAPTA

Monomeric DAPTA

Other Names: Adaptavir, D-Ala1-peptide T-amide, DAPTA, Peptide T, RAP101, mDAPTA, monomeric D-Ala-peptide T-amide Drug Class: CCR5 Antagonist Molecular Formula: C35 H56 N10 O15 Registry Number: 106362-34-9 (CAS) Chemical Name: (D-Ala1) Peptide T Amide; DAPTA  Chemical Class: Peptides Organization: RAPID Pharmaceuticals Phase of Development: II

(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 RAPID Pharmaceuticals press release,3 and Antiviral Research article4)

What is monomeric DAPTA?

What is monomeric DAPTA?

Monomeric DAPTA (mDAPTA) is an investigational drug that has been studied for its ability to eliminate HIV infection that persists despite treatment with antiretroviral therapy (ART). (ART is the recommended treatment for HIV infection and involves using a combination of different antiretroviral [ARV] drugs to prevent HIV from replicating.) Currently, ART can reduce the level of HIV in the blood to an undetectable level, but it can't eliminate HIV entirely from the body.5,6

mDAPTA belongs to a group of HIV drugs called CCR5 antagonists.4 CCR5 antagonists block HIV from getting into and infecting certain cells of the immune system.4 This prevents HIV from multiplying and can reduce the amount of HIV in the body.

The main component of mDAPTA is peptide T. Peptide T was an investigational drug that was previously studied to test its ability to reduce the amount of HIV in the body and bolster the immune system. The drug’s effect on HIV-associated cognitive impairment was also studied.6–8

To learn about how investigational drugs are tested during clinical trials, read the AIDSinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

Which clinical trials are studying monomeric DAPTA?

Which clinical trials are studying monomeric DAPTA?

Peptide T (base compound of mDAPTA)

Study Name: Not available
Phase: Not available
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to examine the ability of peptide T to reduce viral load levels, improve immune function, and reduce HIV replication in blood monocytes (a type of white blood cell that can be infected by HIV).7

Study Name: NCT00000392
Phase: II
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to see whether peptide T could improve the cognitive function (such as memory, language, and thinking) of people with HIV who had cognitive impairment.8,9

 

mDAPTA (the modified version of peptide T)

Study Name: NCT00951743
Phase: II
Status: The recruitment status of this study is unknown.
Location: United States
Purpose: The purpose of this study was to look at the ability of mDAPTA to eliminate HIV that is resistant to current HIV medicines and that hides in certain immune cells. Although these HIV-infected immune cells may be inactive, they can begin to produce HIV at any time.4

For more details on the studies listed above, see the Health Professional version of this drug summary.

What side effects might monomeric DAPTA cause?

What side effects might monomeric DAPTA cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of monomeric DAPTA listed above.

In the first study of peptide T discussed under the previous question, there were no side effects associated with peptide T use among the 11 participants.7

NCT00000392:

In this Phase II study of cognitive function, investigators reported some severe cases of mood disturbance and rash among the participants receiving peptide T, including one case of rash that was life-threatening. (Investigators also reported that some of these cases, especially the mood disturbances, may not have been caused by peptide T use.) Other side effects that occurred in the peptide T group included nasal congestion, abnormal amounts of protein in the urine, and higher than normal amounts of a certain type of white blood cell.8,9 (After these studies were done, peptide T was reformulated as mDAPTA.)

Information on possible side effects of mDAPTA is not complete. As testing of mDAPTA continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying monomeric DAPTA?

Where can I get more information about clinical trials studying monomeric DAPTA?

More information about mDAPTA-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For information, visit NIH Clinical Research Trials and You.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced: Adaptavir. https://chem.nlm.nih.gov/chemidplus/rn/106362-34-9. Accessed August 9, 2018.
  2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed August 9, 2018.
  3. RAPID Pharmaceuticals. Press Release, dated March 4, 2014. RAPID acquires all peptide T clinical data. https://web.archive.org/web/20150513080447/http://www.rapidpharma.com/rapid-acquires-all-peptide-t-clinical-data/. Accessed August 9, 2018.
  4. Polianova MT, Ruscetti FW, Pert CB, Ruff MR. Chemokine receptor-5 (CCR5) is a receptor for the HIV entry inhibitor peptide T (DAPTA). Antivir Res. 2005;67(2):83-92.
  5. Rapid Laboratories Inc. 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. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 31, 2009. NLM Identifier: NCT00951743. https://clinicaltrials.gov/ct2/show/NCT00951743. Accessed August 9, 2018.
  6. RAPID Pharmaceuticals website. Monomeric DAPTA – the long path to discovery. http://www.rapidpharma.com/en/research-developement/technology-platform/path-to-discovery.html. Accessed March 31, 2014.
  7. Polianova MT, Ruscetti FW, Pert CB, et al. Antiviral and immunological benefits in HIV patients receiving intranasal peptide T (DAPTA). Peptides. 2003 Jul;24(7):1093-8. Available at: http://www.rapidpharma.com/uploads/media/2003-02_Publication.pdf. Accessed March 31, 2014.
  8. Heseltine PN, Goodkin K, Atkinson JH, et al. Randomized double-blind placebo-controlled trial of peptide T for HIV-associated cognitive impairment. Arch Neurol. 1998;55(1):41-51.
  9. National Institute of Mental Health (NIMH). Phase II study of the efficacy of peptide T in HIV-positive individuals with cognitive impairment. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 17, 2000. NLM Identifier: NCT00000392. https://clinicaltrials.gov/ct2/show/NCT00000392. Accessed August 9, 2018.

Last Reviewed: August 9, 2019