NCT00276991

Brief Summary

This research work is important for the cure/control of HIV infection. The objectives of a treatment case on HIV patient is essentially to bring down the viral load closer to undetectable level. The studies are depend on the potential influence of 'Kallunk Oxide' on the CD4+ T cells and the effectiveness on surface of HIV-1. The basic study is to break surface protein and directly inhibit a protein's increased functions, not only in the CD4+T cell but also CD3 and CD8+ T cells, by appropriate antidote. The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and lifestyle can be more easily studied.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
1.8 years until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

January 12, 2006

Last Update Submit

November 2, 2015

Conditions

HIV Infections

Keywords

Prolonged Viral SuppressionHIV Infections

Outcome Measures

Primary Outcomes (1)

  • SafeDose,

    Six months follow up

Secondary Outcomes (3)

  • Viral Load Assay

    Three months follow up

  • Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells)

    Three months follow up in Phase - II study

  • Prolonged Viral Suppression

    Six Month's Follow up study( In Phase-II Study)

Study Arms (1)

"Kallunk oxide (Immunotherapy)"

OTHER

The participants were received a daily regimen of "Kallunk oxide(Immunotherapy)" .

Drug: "Kallunk oxide (Immunotherapy) "

Interventions

"Kallunk oxide (Immunotherapy) "DRUG

The study was assigned only one Arm \>450 cu/mm\^3 of baseline CD + T cells. HIV type-1 subjects were received one drug, a daily regimen of "Kallunk oxide(Immunotherapy) + Long Pepper", that is a combination of a traditional alternative medicine(Complementary and Alternative Medicine CAM) as "Kallunk oxide" and appropriate drug carrier antidote. The drug assigns to 0.100 mg and 0.200 mg "Kallunk oxide" molecules with 199.900 mg, and 499.800 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 200 mg for children and 500 mg for adults. This powder form sample size product was administered once daily dose on 5 days treatment. The Botanical name of the antidote is "Piper Longum".

Also known as: 'Kallide'
"Kallunk oxide (Immunotherapy)"

Eligibility Criteria

Age8 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of HIV/AIDS
  • Able to swallow tablets or powder form medicine
  • Able to eat nutritional foods
  • HIV infected patients
  • Signed consent of parent or guardian for patients under 21 years of age
  • Interest to use of study drugs
  • Follow at a participating clinical site and
  • Children of any age (greater than 8 years old)

You may not qualify if:

  • Medical side effects
  • Pregnant or breast feedings
  • History of significant cardiac abnormalities or dysfunction
  • Anti Retro viral Treatment ART used patients
  • Received certain drugs or treatments
  • Unable to followed at a participating clinical center
  • Children less than 8 years old
  • Any serious conditions (severe chronic stage AIDS cases) at study entry that may affect the results of the study.
  • Allergy to any of the study drugs or their formulations
  • Tobacco using patients
  • Alcohol using patients and
  • Drug addicting patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO

Mumbai, 414002, India

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Ramakrishnan Madhusoodanan, PHD

    Traditional Alternative Medicine Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Traditional Alternative Medicine Research Center TAMRC-INDIA.

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

November 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations

IN(1)