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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Page 1 of 1 (4 locations)

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