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HIVNCT00737724

Simultaneous Versus Sequential Antiretroviral Therapy (ARV) Therapy and Mycobacterium Tuberculosis (MTB) Treatment

A study testing Simultaneous ARV and antiMTB and Deferred RV and antiMTB treatment in people with HIV and AIDS, run by Instituto Nacional de Enfermedades Respiratorias at 2 sites in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and HIV infection in patients with AIDS and active tuberculosis. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV, AIDS, Tuberculosis
What is being tested?
Simultaneous ARV and antiMTB and Deferred RV and antiMTB treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
2 sitesMexico
Study dates
Mar 2008to Feb 2011
Phase
Interventional
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • HIV infected
  • < 200 CD4+ cells/mL
  • Active pulmonary tuberculosis (with or without extrapulmonary involvement)

Who cannot join

  • Meningeal tuberculosis
  • Unable to attend 96 wk follow-up

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 45235

  • Centro de Investigaciones en Enfermedades Infecciosas

    Mexico City, Mexico City, 14080

Other trials in Mexico

About this study

Official title: Efficacy of Simultaneous Versus Sequential Antiretroviral Therapy and Antituberculosis Treatment in Patients With AIDS and Active Tuberculosis. Open, Randomized and Controlled, Multisite Clinical Trial.

The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and HIV infection in patients with AIDS and active tuberculosis.

Read the detailed description

AIDS and tuberculosis are two international and national priority public health problems. The best time for starting antiretroviral therapy in patients with AIDS and active tuberculosis is not clear, despite of the guidelines regarding CD4+ count. The debate surrounding this issue is mainly due to the difficulty among adherence of anti-MTb and anti-HIV treatment, the pharmacological interaction, the adverse events related to drugs and the risk of inflammatory reconstitution syndrome, especially in patients with advanced HIV infection. Moreover, there is great debate upon the lack of knowledge of the degree of immune reconstitution throughout time against Mtb induced by the anti-HIV therapy.

Conditions
HIV, AIDS, Tuberculosis
Being tested
Simultaneous ARV and antiMTB, Deferred RV and antiMTB treatment
Keywords
Enzyme-Linked ImmunoSpot, Deferred treatment, Immune Recovery Inflammatory Syndrome
Medical subject headings
Acquired Immunodeficiency Syndrome, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simultaneous ARV and antiMTBDrug

    Also called HAART, isoniazid, Efavirenz, Truvada

    Receives both, simultaneously antiretroviral therapy and antituberculosis therapy

  • Deferred RV and antiMTB treatmentDrug

    Also called HAART, isoniazid, Efavirenz, Truvada

    Receives only antituberculosis therapy and 2 months afterwards antiretroviral therapy

Study groups in NCT00737724
Study groupRoleWhat they receive
Group 1ExperimentalReceives both, simultaneously antiretroviral therapy and antituberculosis therapy
Receives: Drug: Simultaneous ARV and antiMTB
Group 2ExperimentalReceives only antituberculosis therapy, and 2 months afterwards antiretroviral therapy
Receives: Drug: Deferred RV and antiMTB treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to remission of signs and symptoms of active tuberculosis as well as general symptoms.

    Measured: 96 wk

  2. Time to negative measurement of mycobacterial load in body fluids or affected tissues

    Measured: 24 wk

Secondary outcomes (3)

  1. CD4+ cell count increase

    Measured: 24 wk

  2. Lymphoproliferative response to specific antigens against Mtb

    Measured: 24 wk

  3. Time to undetectable HIV plasma load; HIV genotype

    Measured: 24 wk

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Why it stopped: Other published trials showed definitive expected superiority of Group 1

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00737724
Sponsor's protocol ID
C43-06
Status last verified
Mar 2015
First submitted
19 Aug 2008
Last updated
26 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Raviglione MC, Narain JP, Kochi A. HIV-associated tuberculosis in developing countries: clinical features, diagnosis, and treatment. Bull World Health Organ. 1992;70(4):515-26.

    PubMed 1394786

  • De Cock KM, Soro B, Coulibaly IM, Lucas SB. Tuberculosis and HIV infection in sub-Saharan Africa. JAMA. 1992 Sep 23-30;268(12):1581-7. doi: 10.1001/jama.268.12.1581.

    PubMed 1518113

  • Whalen C, Horsburgh CR, Hom D, Lahart C, Simberkoff M, Ellner J. Accelerated course of human immunodeficiency virus infection after tuberculosis. Am J Respir Crit Care Med. 1995 Jan;151(1):129-35. doi: 10.1164/ajrccm.151.1.7812542.

    PubMed 7812542

  • Goletti D, Weissman D, Jackson RW, Graham NM, Vlahov D, Klein RS, Munsiff SS, Ortona L, Cauda R, Fauci AS. Effect of Mycobacterium tuberculosis on HIV replication. Role of immune activation. J Immunol. 1996 Aug 1;157(3):1271-8.

    PubMed 8757635

  • Chaisson RE, Clermont HC, Holt EA, Cantave M, Johnson MP, Atkinson J, Davis H, Boulos R, Quinn TC, Halsey NA. Six-month supervised intermittent tuberculosis therapy in Haitian patients with and without HIV infection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1034-8. doi: 10.1164/ajrccm.154.4.8887603.

    PubMed 8887603

  • Small PM, Schecter GF, Goodman PC, Sande MA, Chaisson RE, Hopewell PC. Treatment of tuberculosis in patients with advanced human immunodeficiency virus infection. N Engl J Med. 1991 Jan 31;324(5):289-94. doi: 10.1056/NEJM199101313240503.

    PubMed 1898769

  • Burman WJ, Jones BE. Treatment of HIV-related tuberculosis in the era of effective antiretroviral therapy. Am J Respir Crit Care Med. 2001 Jul 1;164(1):7-12. doi: 10.1164/ajrccm.164.1.2101133. No abstract available.

    PubMed 11435232

  • Dean GL, Edwards SG, Ives NJ, Matthews G, Fox EF, Navaratne L, Fisher M, Taylor GP, Miller R, Taylor CB, de Ruiter A, Pozniak AL. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. AIDS. 2002 Jan 4;16(1):75-83. doi: 10.1097/00002030-200201040-00010.

    PubMed 11741165

  • Narita M, Ashkin D, Hollender ES, Pitchenik AE. Paradoxical worsening of tuberculosis following antiretroviral therapy in patients with AIDS. Am J Respir Crit Care Med. 1998 Jul;158(1):157-61. doi: 10.1164/ajrccm.158.1.9712001.

    PubMed 9655723

  • Lawn SD, Bekker LG, Wood R. How effectively does HAART restore immune responses to Mycobacterium tuberculosis? Implications for tuberculosis control. AIDS. 2005 Jul 22;19(11):1113-24. doi: 10.1097/01.aids.0000176211.08581.5a.

    PubMed 15990564

  • de Jong BC, Israelski DM, Corbett EL, Small PM. Clinical management of tuberculosis in the context of HIV infection. Annu Rev Med. 2004;55:283-301. doi: 10.1146/annurev.med.55.091902.103753.

    PubMed 14746522

  • Orlovic D, Smego RA Jr. Paradoxical tuberculous reactions in HIV-infected patients. Int J Tuberc Lung Dis. 2001 Apr;5(4):370-5.

    PubMed 11334257

Questions about this trial

What is this clinical trial studying?

A study testing Simultaneous ARV and antiMTB and Deferred RV and antiMTB treatment in people with HIV and AIDS, run by Instituto Nacional de Enfermedades Respiratorias at 2 sites in Mexico.

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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Other published trials showed definitive expected superiority of Group 1). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to remission of signs and symptoms of active tuberculosis as well as general symptoms. (time frame: 96 wk). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00737724, which also lists 12 linked publications.

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 26 Mar 2015.

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