NCT01392430

Brief Summary

The purpose of this study is to compare the incidence of opportunistic infections between HIV-infected patients who continue and discontinue primary or secondary prophylaxis for opportunistic infections in whom receiving combination antiretroviral therapy and achieve undetectable HIV-1 RNA, but CD4 cell counts are less than 200 cells/mm3.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

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

June 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 17, 2012

Status Verified

May 1, 2012

Enrollment Period

2.6 years

First QC Date

July 11, 2011

Last Update Submit

May 16, 2012

Conditions

HIV Infection

Keywords

Primary prophylaxisSecondary prophylaxisDiscontinuation

Outcome Measures

Primary Outcomes (1)

  • Incidence of opportunistic infections

    To test whether the incidence of opportunistic infections differs between these 2 groups * Patients receiving cART and discontinue primary or secondary prophylaxis if their HIV-1 RNA achieve undetectable level. * Patients receiving cART and continue primary or secondary prophylaxis even if HIV-1 RNA achieve undetectable level.

    Participants will be followed up to 135 weeks

Study Arms (2)

Arm A

NO INTERVENTION

Continuation of prophylaxis of opportunistic infections

Arm B

EXPERIMENTAL

Discontinuation of opportunistic infections

Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin

Interventions

Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycinOTHER

Discontinuation of prophylaxis for opportunistic infections

Arm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old
  • regularly receiving highly active antiretroviral therapy (HAART) during follow up
  • CD4 cell count \< 200 cells/mm3
  • HIV-1 RNA \< 50 copies/ml after receiving HAART
  • receiving primary or secondary prophylaxis for opportunistic infections including infections caused by Pneumocystis jiroveci, Cryptococcus neoformans, Penicilliosis marneffei, Histoplasma capsulatum, Toxoplasma gondii, Mycobacterium avium complex
  • given written informed consent

You may not qualify if:

  • \) pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

Muang, Chiang Mai, 50130, Thailand

Location

Related Publications (1)

  • Chaiwarith R, Praparattanapan J, Nuntachit N, Kotarathitithum W, Supparatpinyo K. Discontinuation of primary and secondary prophylaxis for opportunistic infections in HIV-infected patients who had CD4+ cell count <200 cells/mm(3) but undetectable plasma HIV-1 RNA: an open-label randomized controlled trial. AIDS Patient Care STDS. 2013 Feb;27(2):71-6. doi: 10.1089/apc.2012.0303.

    PMID: 23373662DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

DapsoneFluconazoleItraconazoleAzithromycin

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)

SulfonesSulfur CompoundsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Romanee Chaiwarith, MD, MHS.

    Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

June 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 17, 2012

Record last verified: 2012-05

Locations

TH(1)