HIV InfectionsPhase 2NCT00000916

A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood

A Phase 2 study testing Indinavir sulfate, Lamivudine/Zidovudine and Hydroxyurea in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications. It will follow the effect of these medication changes, including the addition of hydroxyurea (HU), on long-term viral suppression. 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?: Indinavir sulfate, Lamivudine/Zidovudine and Hydroxyurea
How many people: 399 participants
Where: 34 sitesUnited States
Study dates: Start not givento Aug 2004
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

You may be eligible for this study if you:
Are 13 years or older.
Have documented HIV-1 infection.
Are currently receiving combined IDV, ZDV(or D4T), and 3TC for at least 6 consecutive months, resulting in HIV RNA less than 200 copies/ml and CD4 cell count greater than 200 cells/mm3.
Had a CD4 count greater than 100 cells/mm3 before starting current anti-HIV therapy.
Are of childbearing age and agree to practice abstinence or use of combined barrier and hormonal methods of birth control during and for 3 months after the study.

Who cannot join

You will not be eligible for this study if you:
Have taken various medications and have various laboratory results (see technical abstract).
Have cancer requiring chemotherapy.
Have an unexplained fever for 7 days or diarrhea for 15 days in the month before the start of the study.
Had prior peripheral neuropathy or hepatitis.
Recently underwent radiation, experimental, or infection therapy.
Are pregnant or breastfeeding.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

University of Colorado Hospital CRS
Aurora, Colorado, 80262
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
Unc Aids Crs
Chapel Hill, North Carolina, 275997215
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, 28203
Northwestern University CRS
Chicago, Illinois, 60611
Weiss Memorial Hosp.
Chicago, Illinois, 60640
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405
Case CRS
Cleveland, Ohio, 44106
MetroHealth CRS
Cleveland, Ohio, 441091998
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 432101228
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, 27401
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 462025250
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, 52242
Univ. of Miami AIDS CRS
Miami, Florida, 331361013
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana, 70112
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Beth Israel Med. Ctr., ACTU
New York, New York
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 681985130
Stanford CRS
Palo Alto, California, 943055107
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, 921036325
San Mateo County AIDS Program
San Mateo, California, 943055107
University of Washington AIDS CRS
Seattle, Washington, 98104
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Washington U CRS
St Louis, Missouri
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502

Other trials in United States

About this study

Official title: A Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copies/ml of HIV RNA in the Plasma

Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more. Discontinuation of one or two of these drugs results in prompt loss of the viral suppression. Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects. This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression.

Read the detailed description

Previous ACTG studies show that discontinuation of one or two of a three-drug regimen (IDV, ZDV, 3TC) leads to prompt loss of viral suppression in the plasma. In this trial, it will be determined whether adding hydroxyurea (HU) to a suppressive regimen increases long term viral suppression. Important safety information on the tolerance of HU regimen will be characterized in asymptomatic patients with viral suppression.

Patients are equally randomized to one of three arms and receive treatment as follows:Arm A: IDV plus ddI plus d4T plus HU placebo. Arm B: IDV plus ddI plus d4T plus HU. Arm C: IDV plus 3TC/ZDV (or d4T plus 3TC). Patients are monitored every 8 weeks with plasma HIV RNA levels and CD4 cell counts.

Conditions: HIV Infections
Being tested: Indinavir sulfate, Lamivudine/Zidovudine, Hydroxyurea, Lamivudine, Stavudine
Keywords: Drug Therapy, Combination, HIV Protease Inhibitors, Hydroxyurea, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Indinavir sulfateDrug
Lamivudine/ZidovudineDrug
HydroxyureaDrug
LamivudineDrug
StavudineDrug
ZidovudineDrug
DidanosineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

?Aug 2004

First posted31 Aug 2001 (estimated)
Study completionAug 2004

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
Enrolment: 399 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00000916
Sponsor's protocol ID: A5025
Other IDs: 10873, ACTG A5025
Status last verified: Oct 2021
First submitted: 2 Nov 1999
Last updated: 29 Oct 2021
Results posted: No

Publications

Havlir DV, Gilbert PB, Bennett K, Collier AC, Hirsch MS, Tebas P, Adams EM, Wheat LJ, Goodwin D, Schnittman S, Holohan MK, Richman DD; ACTG 5025 Study Group. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS. 2001 Jul 27;15(11):1379-88. doi: 10.1097/00002030-200107270-00007.
PubMed 11504959

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copies/ml of HIV RNA in the Plasma
ClinicalTrials.gov ID: NCT00000916
Acronym / sponsor ID: A5025
Conditions: HIV Infections
Keywords: Drug Therapy, Combination, HIV Protease Inhibitors, Hydroxyurea, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 399 participants
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study completion: Aug 2004 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Are 13 years or older.
Have documented HIV-1 infection.
Are currently receiving combined IDV, ZDV(or D4T), and 3TC for at least 6 consecutive months, resulting in HIV RNA less than 200 copies/ml and CD4 cell count greater than 200 cells/mm3.
Had a CD4 count greater than 100 cells/mm3 before starting current anti-HIV therapy.
Are of childbearing age and agree to practice abstinence or use of combined barrier and hormonal methods of birth control during and for 3 months after the study.

Key exclusion criteria (7 listed)

Have taken various medications and have various laboratory results (see technical abstract).
Have cancer requiring chemotherapy.
Have an unexplained fever for 7 days or diarrhea for 15 days in the month before the start of the study.
Had prior peripheral neuropathy or hepatitis.
Recently underwent radiation, experimental, or infection therapy.

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
Indinavir sulfate	Drug	–
Lamivudine/Zidovudine	Drug	–
Hydroxyurea	Drug	–
Lamivudine	Drug	–
Stavudine	Drug	–
Zidovudine	Drug	–
Didanosine	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 29 Oct 2021.
Background: PubMed 11504959Havlir DV, Gilbert PB, Bennett K, Collier AC, Hirsch MS, Tebas P, Adams EM, Wheat LJ, Goodwin D, Schnittman S, Holohan MK, Richman DD; ACTG 5025 Study Group. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS. 2001 Jul 27;15(11):1379-88. doi: 10.1097/00002030-200107270-00007.

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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; Richman D study chair

Collier A study chair

Hirsch M study chair

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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?

On the ClinicalTrials.gov record for NCT00000916, 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 29 Oct 2021.