HIV InfectionsPhase 2NCT00002322
A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
A Phase 2 study testing Atevirdine mesylate and Zidovudine in people with HIV Infections, run by Pharmacia and Upjohn at 12 sites in United States.
Trial summary
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Atevirdine mesylate and Zidovudine
- How many people
- Not given
- Where
- 12 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Primary or secondary prophylaxis for opportunistic infections.
- Patients must have:
- HIV infection.
- Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED:
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- Cryptococcosis
- Pneumocystis carinii pneumonia
- Herpes zoster
- Histoplasmosis
- CMV
- Hepatic or renal disease
- Lymphoma.
- CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry.
- Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry.
- Consent of parent, guardian, or person with power of attorney if less than 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- Intolerance to AZT.
- Current diagnosis of malignancy for which systemic therapy will be required during the study.
- Concurrent Medication:
- Excluded:
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- Any other investigational drugs.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapy within 1 month prior to study entry.
- Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors.
- Antiretroviral agents other than AZT within 3 months prior to study entry.
- Required:
- AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins Hosp
Baltimore, Maryland, 212052196
Boston City Hosp / FGH-1
Boston, Massachusetts, 02118
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
Park Plaza Hosp
Houston, Texas, 77004
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90033
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, 53202
UCI Med Ctr
Orange, California, 92668
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
Davies Med Ctr
San Francisco, California, 94114
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).
Read the detailed description
Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.
- Conditions
- HIV Infections
- Being tested
- Atevirdine mesylate, Zidovudine
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atevirdine mesylateDrug
ZidovudineDrug
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.
- 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 2
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pharmacia and Upjohn
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002322
- Sponsor's protocol ID
- 210A
- Other IDs
- M/3330/0018
- Status last verified
- Nov 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients
- ClinicalTrials.gov ID
- NCT00002322
- Acronym / sponsor ID
- 210A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Pharmacia and UpjohnIndustry (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.
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).
Detailed description
Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Primary or secondary prophylaxis for opportunistic infections.
- HIV infection.
- Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED:
- Cryptococcosis
- Pneumocystis carinii pneumonia
Key exclusion criteria (14 listed)
- Intolerance to AZT.
- Current diagnosis of malignancy for which systemic therapy will be required during the study.
- Any other investigational drugs.
- Cytotoxic chemotherapy within 1 month prior to study entry.
- Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors.
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 |
|---|---|---|
| Atevirdine mesylate | Drug | – |
| Zidovudine | 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.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atevirdine mesylate and Zidovudine in people with HIV Infections, run by Pharmacia and Upjohn at 12 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 16 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 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 12 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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.