HIV InfectionsPhase 2NCT00001068
A Study of Disease Progression and Anti-HIV Treatments
A Phase 2 study testing Lamivudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 41 sites in 3 countries.
Trial summary
To determine the influence of virus load, CD4 count, biologic phenotype, and presence of symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen. PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment for 6 months. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lamivudine
- How many people
- 210 participants
- Where
- 41 sitesin 3 countries
- Study dates
- Start not givento Oct 1998
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Prior participation on protocol ACTG 175.
- PER AMENDMENT 8/27/96:
- Patients must be on study/on treatment at the time the protocol study treatment is extended.
Who cannot join
None listed.
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
United States39 sites
Emory Univ. Hemophilia Program Office
Atlanta, Georgia, 30365
University of Colorado Hospital CRS
Aurora, Colorado
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Bmc Actg Crs
Boston, Massachusetts, 02118
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Unc Aids Crs
Chapel Hill, North Carolina, 27599
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, 28203
Northwestern University CRS
Chicago, Illinois, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
Case CRS
Cleveland, Ohio, 44106
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, 27401
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana
USC CRS
Los Angeles, California, 90033
UCLA CARE Center CRS
Los Angeles, California, 90095
Univ. of Miami AIDS CRS
Miami, Florida, 33136
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Cornell University A2201
New York, New York, 10021
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 68198
Stanford CRS
Palo Alto, California, 94115
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Ucsd, Avrc Crs
San Diego, California
Ucsf Aids Crs
San Francisco, California, 94110
Santa Clara Valley Med. Ctr.
San Jose, California, 95128
University of Washington AIDS CRS
Seattle, Washington, 98122
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri
Washington U CRS
St Louis, Missouri
San Mateo County AIDS Program
Stanford, California, 94305
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502
About this study
Official title: Influence of Risk Status for Disease Progression on the Response to Antiretroviral Interventions: A Follow-up Study to ACTG 175
To determine the influence of virus load, CD4 count, biologic phenotype, and presence of symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen. PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment for 6 months.
- Conditions
- HIV Infections
- Being tested
- Lamivudine
- Keywords
- Zalcitabine, Didanosine, Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents, Zidovudine, Lamivudine
- 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.
LamivudineDrug
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 completionOct 1998
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 210 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001068
- Sponsor's protocol ID
- ACTG 303
- Other IDs
- 11278
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Albrecht MA, Hughes MD, Liou SH, Katzenstein DA, Murphy R, Balfour HH, Para MF, Valdez H, Hammer SM; ACTG 303 Study Team. Effect of lamivudine in HIV-infected persons with prior exposure to zidovudine/didanosine or zidovudine/zalcitabine. AIDS Res Hum Retroviruses. 2000 Sep 20;16(14):1337-44. doi: 10.1089/08892220050140883.
PubMed 11018853
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Risk Status for Disease Progression on the Response to Antiretroviral Interventions: A Follow-up Study to ACTG 175
- ClinicalTrials.gov ID
- NCT00001068
- Acronym / sponsor ID
- ACTG 303
- Conditions
- HIV Infections
- Keywords
- Zalcitabine, Didanosine, Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents, Zidovudine, Lamivudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 1998 (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 determine the influence of virus load, CD4 count, biologic phenotype, and presence of symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen. PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Prior participation on protocol ACTG 175.
- Patients must be on study/on treatment at the time the protocol study treatment is extended.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lamivudine | 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 4 Nov 2021.
- Background: PubMed 11018853Albrecht MA, Hughes MD, Liou SH, Katzenstein DA, Murphy R, Balfour HH, Para MF, Valdez H, Hammer SM; ACTG 303 Study Team. Effect of lamivudine in HIV-infected persons with prior exposure to zidovudine/didanosine or zidovudine/zalcitabine. AIDS Res Hum Retroviruses. 2000 Sep 20;16(14):1337-44. doi: 10.1089/08892220050140883.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamivudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 41 sites in 3 countries.
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 0 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Puerto Rico, Tanzania. 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?
On the ClinicalTrials.gov record for NCT00001068, 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 4 Nov 2021.