Expired Study
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Baltimore, Maryland 21205


Purpose:

To study the anti-HIV activity of the various doses of Ro 24-7429 monotherapy based on virologic and immunologic endpoints. To study the safety and tolerance of Ro 24-7429. To explore relationships between exposure to Ro 24-7429 and its metabolites and antiviral activity and drug toxicity. To determine a safe, tolerable, and active dose regimen of Ro 24-7429, and to make preliminary observations of Ro 24-7429 in combination with another antiretroviral nucleoside. The HIV genome contains a number of genes that regulate viral replication. Control of the activity of these genes and their encoded proteins represents a potential target for development of new antiretroviral drugs. The tat (transactivator of transcription of HIV) antagonist Ro 24-7429 is the first compound for clinical testing that utilizes this approach for therapy of HIV infection.


Study summary:

The HIV genome contains a number of genes that regulate viral replication. Control of the activity of these genes and their encoded proteins represents a potential target for development of new antiretroviral drugs. The tat (transactivator of transcription of HIV) antagonist Ro 24-7429 is the first compound for clinical testing that utilizes this approach for therapy of HIV infection. Ninety-six patients (four treatment arms of 24 patients each) are randomized to receive oral Ro 24-7429 at 1 of 3 doses or nucleoside control (either zidovudine or didanosine). The study will be blinded only for the arms receiving Ro 24-7429. Treatment continues for 12 weeks. After 12 weeks, patients on the nucleoside control arm receive the highest tolerated dose of Ro 24-7429 in addition to their nucleoside.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Chemoprophylaxis for P. carinii pneumonia, TB, and mucocutaneous candidiasis. - Methadone maintenance. - Hormonal contraceptives. Patients must have: - HIV-1 seropositivity. - CD4 count 50 - 500 cells/mm3. - Life expectancy of at least 24 weeks. - Stable weight (+/- 2 kg) by 28 days prior to study entry (by history). NOTE: - At least 50 percent of patients must be p24 antigen positive (>= 50 pg/ml). Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Known or suspected hypersensitivity to benzodiazepines. - Presence of any malignancy other than basal cell carcinoma or limited cutaneous Kaposi's sarcoma (defined as no more than five lesions with no mucosal involvement). - Ongoing diarrhea, defined as more than 2 liquid stools per day. - History, physical exam, or laboratory results consistent with a subclinical AIDS-defining opportunistic infection. - Grade 2 or greater signs and symptoms of AIDS Dementia Complex. - Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease. Concurrent Medication: Excluded: - Chronic suppressive therapy for CMV, MAI, toxoplasmosis, cryptococcosis, cryptosporidiosis, coccidioidomycosis, and histoplasmosis. - ddC, ddI, AZT (except for control groups) or other experimental antiretrovirals or immunomodulating agents. - Other medications excluded from the study. Patients with the following prior conditions are excluded: - History of serious adverse reactions to benzodiazepines. - History of intolerance to AZT at 600 mg/day or less or ddI at 400 mg/day or less. - History of unexplained fever, defined as a temperature of 38.5 deg C or greater with or without night sweats for more than 7 of the past 28 days. Prior Medication: Excluded: - Benzodiazepines within 14 days prior to study entry. Active drug or alcohol abuse that would interfere with study compliance.


Study is Available At:


Original ID:

ACTG 213


NCT ID:

NCT00000760


Secondary ID:

NV14224A


Study Acronym:


Brief Title:

A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection


Official Title:

A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

96


Enrollment Type:


Overall Contact Information

Official Name:Richman DD
Study Chair

Study Dates

Verification Date:November 1998
Last Changed Date:July 31, 2008
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Ro 24-7429
Intervention Type:Drug
Name:Zidovudine
Intervention Type:Drug
Name:Didanosine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Lathey JL, Marschner IC, Kabat B, Spector SA. Deterioration of detectable human immunodeficiency virus serum p24 antigen in samples stored for batch testing. J Clin Microbiol. 1997 Mar;35(3):631-5.
PMID:9041402
Reference Type:Reference
Citation:Haubrich RH. A randomized study of safety, tolerance, pharmacokinetics, and activity of oral Ro 24-7429 (TAT antagonist) in patients with HIV infection. The ACTG 213 Team. Int Conf AIDS. 1993 Jun 6-11;9(1):69 (abstract no WS-B26-5)
Reference Type:Reference
Citation:Haubrich RH, Flexner C, Lederman MM, Hirsch M, Pettinelli CP, Ginsberg R, Lietman P, Hamzeh FM, Spector SA, Richman DD. A randomized trial of the activity and safety of Ro 24-7429 (Tat antagonist) versus nucleoside for human immunodeficiency virus infection. The AIDS Clinical Trials Group 213 Team. J Infect Dis. 1995 Nov;172(5):1246-52.
PMID:7594660

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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