HIV InfectionsPhase 1NCT00002237
A Study of Peldesine (BCX-34) in HIV-Infected Patients
A Phase 1 study testing Peldesine in people with HIV Infections, run by BioCryst Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the highest amount of peldesine that is safe. This study will also see if this amount of peldesine is effective in lowering HIV levels in the blood. 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?
- Peldesine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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:
- Documented HIV infection.
- CD4 cell count greater than or equal to 300 cells/mm3 on 3 occasions prior to protocol treatment.
- Plasma viral load by Roche Amplicor HIV Monitor assay greater than or equal to 2,000 RNA copies/ml and less than or equal to 50,000 RNA copies/ml on at least 2 occasions prior to protocol treatment.
- Normal or non-diagnostic electrocardiogram.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Severe opportunistic infection or any other medical condition which in the opinion of the investigators is a contraindication to enrolling in this trial.
- Severe lactose intolerance.
- Concurrent Medication:
- Excluded:
Show all 13Show fewer
- Concomitant therapy with other medications having primary renal excretion (other than 3TC, ddC, and d4T).
- Prior Medication:
- Excluded:
- Ongoing dideoxyinosine or other antiretroviral therapy except ZDV, 3TC, ddC, d4T, saquinavir, ritonavir, indinavir, and nelfinavir within 2 weeks of study.
- Participation in a study of any systemic experimental drug within the last 2 months.
- Required:
- Ongoing (at least 4 weeks) stable dosage of zidovudine (ZDV) and lamivudine (3TC), ZDV and stavudine (d4T), ZDV and zalcitabine (ddC), d4T and 3TC, ZDV alone, or ddC alone, or in combination with saquinavir, ritonavir, indinavir, or nelfinavir.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
About this study
Official title: Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients
The purpose of this study is to determine the highest amount of peldesine that is safe. This study will also see if this amount of peldesine is effective in lowering HIV levels in the blood.
Read the detailed description
Patients are given either BCX-35 or placebo for 14 or 28 days. Plasma viral load will be determined at the MTD.
- Conditions
- HIV Infections
- Being tested
- Peldesine
- Keywords
- Placebos, Administration, Oral, Anti-HIV Agents, Viral Load, peldesine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeldesineDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002237
- Sponsor's protocol ID
- 301A
- Other IDs
- 96-009
- Status last verified
- Sep 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Mboup A, Diabate S, Behanzin L, Guedou FA, Zannou DM, Keke RK, Bachabi M, Gangbo F, Marzinke MA, Hendrix C, Gagnon MP, Alary M. Determinants of HIV Preexposure Prophylaxis Adherence Among Female Sex Workers in a Demonstration Study in Cotonou, Benin: A Study of Behavioral and Demographic Factors. Sex Transm Dis. 2021 Aug 1;48(8):565-571. doi: 10.1097/OLQ.0000000000001373.
PubMed 33448731Mboup A, Behanzin L, Guedou FA, Geraldo N, Goma-Matsetse E, Giguere K, Aza-Gnandji M, Kessou L, Diallo M, Keke RK, Bachabi M, Dramane K, Geidelberg L, Cianci F, Lafrance C, Affolabi D, Diabate S, Gagnon MP, Zannou DM, Gangbo F, Boily MC, Vickerman P, Alary M. Early antiretroviral therapy and daily pre-exposure prophylaxis for HIV prevention among female sex workers in Cotonou, Benin: a prospective observational demonstration study. J Int AIDS Soc. 2018 Nov;21(11):e25208. doi: 10.1002/jia2.25208.
PubMed 31291057
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002237
- Acronym / sponsor ID
- 301A
- Conditions
- HIV Infections
- Keywords
- Placebos, Administration, Oral, Anti-HIV Agents, Viral Load, peldesine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- 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.
The purpose of this study is to determine the highest amount of peldesine that is safe. This study will also see if this amount of peldesine is effective in lowering HIV levels in the blood.
Detailed description
Patients are given either BCX-35 or placebo for 14 or 28 days. Plasma viral load will be determined at the MTD.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented HIV infection.
- CD4 cell count greater than or equal to 300 cells/mm3 on 3 occasions prior to protocol treatment.
- Plasma viral load by Roche Amplicor HIV Monitor assay greater than or equal to 2,000 RNA copies/ml and less than or equal to 50,000 RNA copies/ml on at least 2 occasions prior to protocol treatment.
- Normal or non-diagnostic electrocardiogram.
Key exclusion criteria (13 listed)
- Severe opportunistic infection or any other medical condition which in the opinion of the investigators is a contraindication to enrolling in this trial.
- Severe lactose intolerance.
- Concomitant therapy with other medications having primary renal excretion (other than 3TC, ddC, and d4T).
- Ongoing dideoxyinosine or other antiretroviral therapy except ZDV, 3TC, ddC, d4T, saquinavir, ritonavir, indinavir, and nelfinavir within 2 weeks of study.
- Participation in a study of any systemic experimental drug within the last 2 months.
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 |
|---|---|---|
| Peldesine | 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 24 Jun 2005.
- Derived from this study: PubMed 33448731Mboup A, Diabate S, Behanzin L, Guedou FA, Zannou DM, Keke RK, Bachabi M, Gangbo F, Marzinke MA, Hendrix C, Gagnon MP, Alary M. Determinants of HIV Preexposure Prophylaxis Adherence Among Female Sex Workers in a Demonstration Study in Cotonou, Benin: A Study of Behavioral and Demographic Factors. Sex Transm Dis. 2021 Aug 1;48(8):565-571. doi: 10.1097/OLQ.0000000000001373.
- Derived from this study: PubMed 31291057Mboup A, Behanzin L, Guedou FA, Geraldo N, Goma-Matsetse E, Giguere K, Aza-Gnandji M, Kessou L, Diallo M, Keke RK, Bachabi M, Dramane K, Geidelberg L, Cianci F, Lafrance C, Affolabi D, Diabate S, Gagnon MP, Zannou DM, Gangbo F, Boily MC, Vickerman P, Alary M. Early antiretroviral therapy and daily pre-exposure prophylaxis for HIV prevention among female sex workers in Cotonou, Benin: a prospective observational demonstration study. J Int AIDS Soc. 2018 Nov;21(11):e25208. doi: 10.1002/jia2.25208.
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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 Phase 1 study testing Peldesine in people with HIV Infections, run by BioCryst Pharmaceuticals 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 5 inclusion and 13 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 24 Jun 2005. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00002237, which also lists 2 linked publications.
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 24 Jun 2005.