HIV InfectionsPhase 2NCT00001067
The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
A Phase 2 study testing Lamivudine, Stavudine and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 2 countries.
Trial summary
To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time. 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, Stavudine and Zidovudine
- How many people
- 105 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Start not givento Nov 1997
- 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
- Concurrent Medication:
- Required:
- TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.
- Allowed:
- Atovaquone.
- IV pentamidine.
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- TMP / SMX.
- Trimetrexate.
- Trimethoprim-dapsone.
- Clindamycin-primaquine.
- Topical antifungals.
- Clotrimazole.
- Ketoconazole.
- Fluconazole.
- Amphotericin B.
- Itraconazole.
- Rifabutin.
- Isoniazid.
- Pyrazinamide.
- Clofazimine.
- Clarithromycin.
- Azithromycin.
- Ethambutol.
- Amikacin.
- Ciprofloxacin.
- Ofloxacin.
- Pyrimethamine.
- Sulfadiazine.
- Clindamycin.
- Filgrastim ( G-CSF ).
- Up to 1000 mg/day acyclovir.
- Erythropoietin.
- Antibiotics.
- Antipyretics.
- Analgesics.
- Antiemetics.
- Rifampin.
- Concurrent Treatment:
- Allowed:
- Local radiation therapy.
- Patients must have:
- HIV infection.
- CD4 count 300 - 600 cells/mm3.
- NO history of AIDS.
- NO active opportunistic infection.
- NO prior nucleoside therapy.
- Life expectancy at least 2 years.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Serious underlying medical condition other than HIV such that life expectancy is less than 2 years.
- Malignancy requiring systemic cytotoxic chemotherapy.
- Active grade 2 or worse peripheral neuropathy.
- Concurrent Medication:
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- Excluded:
- Antiretrovirals other than study drugs.
- Systemic cytotoxic chemotherapy.
- Foscarnet.
- Patients with the following prior conditions are excluded:
- Chronic diarrhea defined as three or more stools per day for 15 days, within 30 days prior to study entry.
- Unexplained temperature >= 38.5 C for any 7 days within 30 days prior to study entry.
- Active participation in other experimental therapy within 30 days prior to study entry.
- Prior Medication:
- Excluded:
- Prior nucleoside antiretrovirals of 1 week or longer duration.
- Any antiretroviral within 90 days prior to study entry.
- Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days prior to study entry.
- Biologic response modifiers such as IL-2 and interferon within 30 days prior to study entry.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
The Ponce de Leon Ctr. CRS
Atlanta, Georgia
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Unc Aids Crs
Chapel Hill, North Carolina, 27599
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016
Stanford CRS
Palo Alto, California, 94305
Ucsd, Avrc Crs
San Diego, California, 92103
Washington U CRS
St Louis, Missouri, 63110
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, 20059
About this study
Official title: A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience
To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time.
Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
Read the detailed description
Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).
- Conditions
- HIV Infections
- Being tested
- Lamivudine, Stavudine, Zidovudine
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Stavudine, 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
StavudineDrug
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)
- Study completionNov 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Enrolment
- 105 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Havlir D, Study chairPollard R, Study chairRichman D, Study chairFriedland G, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001067
- Sponsor's protocol ID
- ACTG 298
- Other IDs
- 11274
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8.
PubMed 11365218Havlir DV, Friedland G, Pollard R, Tierney C, Smeaton L, Fox L, Richman DD. Combination zidovudine (ZDV) and stavudine (d4T) therapy versus other nucleosides: report of two randomized trials (ACTG 290 and 298). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 2)
Pollard RB, Tierney C, Havlir D, Tebas P, Fox L, Smeaton L, Richman D, Friedland GH. A phase II randomized study of the virologic and immunologic effect of zidovudine + stavudine versus stavudine alone and zidovudine + lamivudine in patients with >300 CD4 cells who were antiretroviral naive (ACTG 298). AIDS Res Hum Retroviruses. 2002 Jul 1;18(10):699-704. doi: 10.1089/088922202760072311.
PubMed 12167276
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience
- ClinicalTrials.gov ID
- NCT00001067
- Acronym / sponsor ID
- ACTG 298
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Stavudine, Lamivudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Nov 1997 (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 drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time.
Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
Detailed description
Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (47 listed)
- TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.
- Atovaquone.
- IV pentamidine.
- TMP / SMX.
- Trimetrexate.
Key exclusion criteria (20 listed)
- Serious underlying medical condition other than HIV such that life expectancy is less than 2 years.
- Malignancy requiring systemic cytotoxic chemotherapy.
- Active grade 2 or worse peripheral neuropathy.
- Antiretrovirals other than study drugs.
- Systemic cytotoxic chemotherapy.
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 | – |
| Stavudine | 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 1 Nov 2021.
- Background: PubMed 11365218Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8.
- BackgroundHavlir DV, Friedland G, Pollard R, Tierney C, Smeaton L, Fox L, Richman DD. Combination zidovudine (ZDV) and stavudine (d4T) therapy versus other nucleosides: report of two randomized trials (ACTG 290 and 298). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 2)
- Background: PubMed 12167276Pollard RB, Tierney C, Havlir D, Tebas P, Fox L, Smeaton L, Richman D, Friedland GH. A phase II randomized study of the virologic and immunologic effect of zidovudine + stavudine versus stavudine alone and zidovudine + lamivudine in patients with >300 CD4 cells who were antiretroviral naive (ACTG 298). AIDS Res Hum Retroviruses. 2002 Jul 1;18(10):699-704. doi: 10.1089/088922202760072311.
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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.
Havlir D study chair
Pollard R study chair
Richman D study chair
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamivudine, Stavudine and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 2 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 47 inclusion and 20 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 1 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 13 sites in United States, Puerto Rico. 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 NCT00001067, which also lists 3 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 1 Nov 2021.