HIV InfectionsNCT00002349
A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
A study testing Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Stavudine
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 1995to May 1999
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Recent HIV infection.
- No prior antiretroviral therapy.
- No acute opportunistic infection at study entry.
Who cannot join
- 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:
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Naval Med Ctr
Portsmouth, Virginia, 237085100
San Diego Naval Hosp
San Diego, California, 921345000
Northwest Med Ctr
Seattle, Washington, 98122
About this study
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.
Read the detailed description
Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Stavudine
- Keywords
- AIDS-Related Complex, Stavudine
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StavudineDrug
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 startJan 1995
- Primary completionMay 1999
- Study completionMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002349
- Sponsor's protocol ID
- 244A
- Other IDs
- AI455-029
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 14 Apr 2011
- Results posted
- No
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 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 Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
- ClinicalTrials.gov ID
- NCT00002349
- Acronym / sponsor ID
- 244A
- Conditions
- HIV Infections
- Keywords
- AIDS-Related Complex, Stavudine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 1995
- Primary completion
- May 1999 (actual)
- Study completion
- May 1999 (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 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.
Detailed description
Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent HIV infection.
- No prior antiretroviral therapy.
- No acute opportunistic infection at study entry.
Key exclusion criteria (14 listed)
- Intractable diarrhea.
- Bilateral peripheral neuropathy.
- Any other condition that would preclude study therapy.
- Myelosuppressive, neurotoxic, or hepatotoxic drugs.
- History of bilateral peripheral neuropathy.
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 |
|---|---|---|
| Stavudine | 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.
- BackgroundKatlama 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
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 3 sites 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 4 inclusion and 14 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 3 sites 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?
On the ClinicalTrials.gov record for NCT00002349, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 31 Oct 2026.