A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
To assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of this therapy over CD4 cell counts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 1997
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedApril 14, 2011
April 1, 2011
2.8 years
November 2, 1999
April 13, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Documented HIV infection.
- CD4 count \> 500 cells/mm3.
- No HIV-associated symptoms.
- Written, informed consent from parent or legal guardian for patients \< 18 years old.
- Availability for follow-up for at least 96 weeks.
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions and symptoms are excluded:
- Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
- Intractable diarrhea.
- Signs and symptoms of bilateral peripheral neuropathy \>= Grade 2.
- Inability to tolerate oral medication.
- Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue.
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.
- No other anti-HIV therapy allowed.
- Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed).
- \. Any prior antiretroviral therapy.
- Prior vaccination with a candidate HIV therapeutic vaccine.
- Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
- Previous therapy with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed) within 14 days prior to study entry or at any time while on study.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univ of California at San Francisco Gen Hosp
San Francisco, California, 94110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
May 1, 1997
Primary Completion
March 1, 2000
Study Completion
March 1, 2000
Last Updated
April 14, 2011
Record last verified: 2011-04