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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00000760 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection
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Scientific title:
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A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection |
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Date of first enrolment:
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July 2000 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00000760 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Haubrich R |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Richman DD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: Didanosine
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Drug: Ro 24-7429
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Drug: Zidovudine
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Secondary ID(s)
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ACTG 213
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NV14224A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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