HIV InfectionsNCT00002176
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
A study testing Hydroxyurea, Nelfinavir mesylate and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Hydroxyurea, Nelfinavir mesylate and Stavudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 1997to Mar 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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).
- 1. 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.
- Active alcohol or substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of California at San Francisco Gen Hosp
San Francisco, California, 94110
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Hydroxyurea, Nelfinavir mesylate, Stavudine, Didanosine
- Keywords
- Pilot Projects, Didanosine, Drug Therapy, Combination, Stavudine, Hydroxyurea, Nelfinavir, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxyureaDrug
Nelfinavir mesylateDrug
StavudineDrug
DidanosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startMay 1997
- Primary completionMar 2000
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002176
- Sponsor's protocol ID
- 244C
- Other IDs
- AI455-062
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 14 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection
- ClinicalTrials.gov ID
- NCT00002176
- Acronym / sponsor ID
- 244C
- Conditions
- HIV Infections
- Keywords
- Pilot Projects, Didanosine, Drug Therapy, Combination, Stavudine, Hydroxyurea, Nelfinavir, Anti-HIV Agents, Viral Load
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 1997
- Primary completion
- Mar 2000 (actual)
- Study completion
- Mar 2000 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyurea | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Stavudine | Drug | – |
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyurea, Nelfinavir mesylate and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.