- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002349
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection.
Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 921345000
- San Diego Naval Hosp
-
-
Virginia
-
Portsmouth, Virginia, United States, 237085100
- Naval Med Ctr
-
-
Washington
-
Seattle, Washington, United States, 98122
- Northwest Med Ctr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- Recent HIV infection.
- No prior antiretroviral therapy.
- No acute opportunistic infection at study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Intractable diarrhea.
- Bilateral peripheral neuropathy.
- Any other condition that would preclude study therapy.
Concurrent Medication:
Excluded:
- Myelosuppressive, neurotoxic, or hepatotoxic drugs.
Patients with the following prior condition are excluded:
History of bilateral peripheral neuropathy.
Prior Medication:
Excluded:
- Prior antiretroviral therapy.
- Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Katlama C, Molina JM, Rozenbaum W, Valantin MA, Modai J, Chauveau E, Ngo Van P, Gres JJ. Stavudine ( D4T ) in HIV infected patients with CD4 less than 350/mm3: results of a double-blind randomized placebo controlled study. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:89
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Stavudine
Other Study ID Numbers
- 244A
- AI455-029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Stavudine
-
Groupe Hospitalier Pitie-SalpetriereBristol-Myers SquibbUnknown
-
University of ZimbabweAIDS Care Research in AfricaCompletedHIV Infections | Cryptococcal MeningitisZimbabwe
-
Makerere UniversityDepartment of Foreign Affairs, IrelandCompletedHIV InfectionsUganda
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
University of KwaZuluAIDS Malignancy Consortium; National Research Foundation, Singapore; AIDS Care... and other collaboratorsCompletedHIV | Kaposi's Sarcoma | AIDS | Human Herpesvirus 8South Africa
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States, Puerto Rico, South Africa
-
Makerere UniversityUniversity of California, San FranciscoCompleted
-
Bristol-Myers SquibbCompletedHIV InfectionsUnited States, Puerto Rico
-
Bristol-Myers SquibbCompletedHIV Infections | AIDSBelgium, Portugal, Spain, United States, Argentina, Canada, France, Italy, Mexico, Puerto Rico, Singapore, South Africa, Thailand, Russian Federation, Israel, Brazil
-
National Institute of Allergy and Infectious Diseases...Bristol-Myers SquibbCompleted