Status:
COMPLETED
A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
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 be...
Detailed Description
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 antire...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00000760
Last Update
August 4 2008
Active Locations (4)
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1
UCSD
San Diego, California, United States, 92103
2
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
3
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
4
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106