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Toxoplasmosis, CerebralPhase 2NCT00000643

Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients

A Phase 2 study testing Pyrimethamine and Leucovorin calcium in people with Toxoplasmosis, Cerebral and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the effectiveness of pyrimethamine (given with leucovorin calcium versus placebo (an inactive substance) for the primary prophylaxis (prevention) of cerebral toxoplasmosis in HIV-infected patients. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Toxoplasmosis, Cerebral, HIV Infections
What is being tested?
Pyrimethamine and Leucovorin calcium
How many people
150 participants
Where
24 sitesUnited States
Study dates
Start not givento May 1994
Phase
Phase 2
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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), erythropoietin (Eprex), other agents granted Treatment IND or expanded access status.
  • Investigational triazoles.
  • Pentamidine for primary prophylaxis of Pneumocystis carinii pneumonia (PCP).
  • Patients with the following are excluded:
Show all 13Show fewer
  • History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue.
  • Focal neural abnormalities (except peripheral neuropathy) or mass lesions on a previous computerized tomography (CT) scan or magnetic resonance image (MRI), unless subsequent workup rules out toxoplasmosis, in which case abnormalities must have been stable for at least 2 months.
  • Known or suspected allergy or severe intolerance to study drugs.
  • Patients must have:
  • Positive toxoplasma serology.
  • HIV infection.
  • Willingness and ability to comply with the protocol and capability of giving written informed consent.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Current diagnosis of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue.
  • Known or suspected allergy or severe intolerance to study drugs.
  • Concurrent Medication:
  • Excluded:
  • Anticoagulants. Other antifolates, sulfonamides, fansidar, macrolides, 5-fluorouracil, dapsone, or any other agent with known activity against Toxoplasma gondii.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Bmc Actg Crs

    Boston, Massachusetts, 02118

  • SUNY - Buffalo, Erie County Medical Ctr.

    Buffalo, New York, 14215

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27599

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois, 60611

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio, 45267

  • Case CRS

    Cleveland, Ohio, 44106

  • Duke Univ. Med. Ctr. Adult CRS

    Durham, North Carolina, 27710

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, 46202

  • Univ. of Miami AIDS CRS

    Miami, Florida, 33136

  • University of Minnesota, ACTU

    Minneapolis, Minnesota, 55455

  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU

    New Orleans, Louisiana

  • Beth Israel Med. Ctr. (Mt. Sinai)

    New York, New York, 10003

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Cornell University A2201

    New York, New York, 10021

  • Memorial Sloan-Kettering Cancer Ctr.

    New York, New York, 10021

  • NJ Med. School CRS

    Newark, New Jersey, 07103

  • Stanford CRS

    Palo Alto, California, 94304

  • Pitt CRS

    Pittsburgh, Pennsylvania, 15213

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • St. Louis ConnectCare, Infectious Diseases Clinic

    St Louis, Missouri

  • Washington U CRS

    St Louis, Missouri

  • Harbor-UCLA Med. Ctr. CRS

    Torrance, California, 90502

Other trials in United States

About this study

To evaluate the effectiveness of pyrimethamine (given with leucovorin calcium versus placebo (an inactive substance) for the primary prophylaxis (prevention) of cerebral toxoplasmosis in HIV-infected patients.

Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent. Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients.

Read the detailed description

Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent. Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients.

AMENDED: 04-04-91 On the first day of therapy, a loading dose is given. After the first day, patients take pyrimethamine or placebo 3 times a week. Patients also take leucovorin calcium orally three times weekly. Enrollment occurs over approximately 12 months. All patients are followed on study until a common study close-out date and final analysis of the study. It is anticipated that this common close-out will occur when the mean duration of time on study therapy will be 3 years (approximately in January, 1994).

ORIGINAL design: On the first day of treatment, patients receive a loading dose of pyrimethamine or placebo, plus of leucovorin calcium. After the first day, patients take pyrimethamine or placebo three times a week. Patients also take folinic acid orally three times weekly. The mean duration of study participation is 3 years.

Being tested
Pyrimethamine, Leucovorin calcium
Keywords
Toxoplasmosis, Pyrimethamine, Leucovorin, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Brain Diseases
Medical subject headings
Toxoplasmosis, Cerebral, HIV Infections, Toxoplasmosis, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Brain Diseases

What participants receive

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

Timeline

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

  1. First posted31 Aug 2001 (estimated)
  2. Study completionMay 1994

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 2
Primary purpose
Prevention
Masking
Double blind
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000643
Sponsor's protocol ID
ACTG 154
Other IDs
11129
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
2 Nov 2021
Results posted
No

Publications

  • Rousseau F, Pueyo S, Morlat P, Hafner R, Chene G, Leport C, Luft BJ, Miro J, Aubertin J, Salamon R, Vilde JL. Increased risk of toxoplasmic encephalitis in human immunodeficiency virus-infected patients with pyrimethamine-related rash. ANRS 005-ACTG 154 Trial Group. Agence Nationale de Recherche sur le SIDA (ANRS-INSERM) and the NIAID-AIDS Clinical Trials Group. Clin Infect Dis. 1997 Mar;24(3):396-402. doi: 10.1093/clinids/24.3.396.

    PubMed 9114191

  • Leport C, Chene G, Farinotti R, Ecobichon J-L, Petavin G, Sagardoy G, Morlat P, Hafner R, Luft B, Salamon R, Vilde J-L. Determination of pyrimethamine serum levels in a primary prophylaxis trial for toxoplasmic encephalitis. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:159

  • Leport C, Chene G, Morlat P, Luft BJ, Rousseau F, Pueyo S, Hafner R, Miro J, Aubertin J, Salamon R, Vilde JL. Pyrimethamine for primary prophylaxis of toxoplasmic encephalitis in patients with human immunodeficiency virus infection: a double-blind, randomized trial. ANRS 005-ACTG 154 Group Members. Agence Nationale de Recherche sur le SIDA. AIDS Clinical Trial Group. J Infect Dis. 1996 Jan;173(1):91-7. doi: 10.1093/infdis/173.1.91.

    PubMed 8537688

  • Pueyo S, Salmi LR, Chene G, Leport C, Morlat P, Dequae L, Gregoire V, Hafner R, Vilde JL, Luft BJ, Aubertin J, Salamon R. Survival after AIDS-defining events in patients with < 200 lymphocytes CD4+ x 10(6)/L who are toxoplasmosis antibody positive. ANRS 005/ACTG 154 Trial Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Apr 15;14(5):459-64. doi: 10.1097/00042560-199704150-00010.

    PubMed 9170421

  • Derouin F, Leport C, Pueyo S, Morlat P, Letrillart B, Chene G, Ecobichon JL, Luft B, Aubertin J, Hafner R, Vilde JL, Salamon R. Predictive value of Toxoplasma gondii antibody titres on the occurrence of toxoplasmic encephalitis in HIV-infected patients. ANRS 005/ACTG 154 Trial Group. AIDS. 1996 Nov;10(13):1521-7. doi: 10.1097/00002030-199611000-00010.

    PubMed 8931787

  • Chene G, Morlat P, Hafner R, Aboulker JP, Luft B, Dormont J, Vilde JL, Salamon R. Intent-to-treat versus on treatment analysis: how to interpret the results of a clinical trial? Experience from ANRS 005/ACTG 154 study. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:100

  • Chene G, Morlat P, Leport C, Hafner R, Dequae L, Charreau I, Aboulker JP, Luft B, Aubertin J, Vilde JL, Salamon R. Intention-to-treat vs. on-treatment analyses of clinical trial data: experience from a study of pyrimethamine in the primary prophylaxis of toxoplasmosis in HIV-infected patients. ANRS 005/ACTG 154 Trial Group. Control Clin Trials. 1998 Jun;19(3):233-48. doi: 10.1016/s0197-2456(97)00145-1.

    PubMed 9620807

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrimethamine and Leucovorin calcium in people with Toxoplasmosis, Cerebral and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.

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 13 inclusion and 7 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: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000643, which also lists 7 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 2 Nov 2021.

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