NCT04847388

Brief Summary

Individuals utilise substances to elevate their mood. Alcohol, cannabis, nicotine, cocaine, and methamphetamine are examples of substances. Excessive usage of a drug that is harmful to oneself and society is referred to as substance addiction/abuse. People who inject drugs and share needles, as well as drugs that impair judgement and lead to unprotected intercourse with an infected partner, have been related to risky sex behaviour and unsafe sex, both of which increase the risk of HIV infection. Several factors, including immunologic and virologic conditions affecting host susceptibility, underlying comorbidities among drug users, use of antiretroviral therapy, and viral strain, as well as pharmacodynamic aspects of drug use, such as the pattern and type of drug administration and the route of administration, may mediate the relationship between drug use and HIV disease progression. Exacerbation of HIV progression has been shown in patients with substance addiction in laboratory research.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

April 11, 2021

Last Update Submit

March 16, 2022

Conditions

HIV Infections

Keywords

CD4 T cellHIVSubstance abuse

Outcome Measures

Primary Outcomes (1)

  • Prevalence of substance abuse among anti-retroviral treatment naïve patients positive for HIV antibodies.

    Calculate prevalence (%) dividing no. of HIV patients with substance abuse by total no. of enrolled HIV patient multiplied by 100.

    One year

Secondary Outcomes (2)

  • CD4+ T cell counts at the first visit to ART centre in patients positive for HIV antibodies with substance addiction and without substance addiction.

    One year

  • Opportunistic infections

    One year

Study Arms (2)

ART-naive HIV Patients with substance abuse and without substance abuse

Group A Group B

Drug: Substance like alcohol, marijuana, etc.

Group A and B

Group A: ART-naive HIV seropositive with H/O substance abuse Group B: ART-naive HIV seropositive without H/O substance abuse

Drug: Substance like alcohol, marijuana, etc.

Interventions

Substance like alcohol, marijuana, etc.DRUG

Cohort study

Also known as: Cannabis
ART-naive HIV Patients with substance abuse and without substance abuseGroup A and B

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Treatment naive HIV seropositive patients

You may qualify if:

  • \. Anti-retroviral therapy naïve patients

You may not qualify if:

  • \. 'Transferred in' patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ART centre, Sadar Hospital

Khagaria, Bihar, 851204, India

Location

Related Publications (3)

  • Kapadia F, Vlahov D, Donahoe RM, Friedland G. The role of substance abuse in HIV disease progression: reconciling differences from laboratory and epidemiologic investigations. Clin Infect Dis. 2005 Oct 1;41(7):1027-34. doi: 10.1086/433175. Epub 2005 Aug 22.

    PMID: 16142670BACKGROUND

  • Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Available from http://www.ncbi.nlm.nih.gov/books/NBK201/

    PMID: 21250045BACKGROUND

  • NIDA. 2019, July 29. Drug Use and Viral Infections (HIV, Hepatitis) DrugFacts. Retrieved from https://www.drugabuse.gov/publications/drugfacts/drug-use-viral-infections-hiv-hepatitis on 2021, April 5

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsSubstance-Related Disorders

Interventions

Ethanolnabiximols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Ranjan K Singh

    Consultant Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 11, 2021

First Posted

April 19, 2021

Study Start

April 1, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)