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| ID | Type | Description | Link |
|---|---|---|---|
| 10873 | Registry Identifier | DAIDS ES | |
| ACTG A5025 |
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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. Other medications which may be added include didanosine (ddI) and/or stavudine (d4T).
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir sulfate | Drug | |||
| Lamivudine/Zidovudine | Drug | |||
| Hydroxyurea | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug | |||
| Zidovudine | Drug | |||
| Didanosine | Drug |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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| Name | Affiliation | Role |
|---|---|---|
| Havlir D; Richman D | Study Chair | |
| Collier A | Study Chair | |
| Hirsch M | Study Chair | |
| Tebas P | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294 | United States | ||
| Stanford CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11504959 | Background | 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. |
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| Palo Alto |
| California |
| 943055107 |
| United States |
| Ucsd, Avrc Crs | San Diego | California | 921036325 | United States |
| San Mateo County AIDS Program | San Mateo | California | 943055107 | United States |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | United States |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | United States |
| Univ. of Miami AIDS CRS | Miami | Florida | 331361013 | United States |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | United States |
| Northwestern University CRS | Chicago | Illinois | 60611 | United States |
| Weiss Memorial Hosp. | Chicago | Illinois | 60640 | United States |
| Indiana Univ. School of Medicine, Wishard Memorial | Indianapolis | Indiana | 462025250 | United States |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | United States |
| Univ. of Iowa Healthcare, Div. of Infectious Diseases | Iowa City | Iowa | 52242 | United States |
| Tulane Hemophilia Treatment Ctr. | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital ACTG CRS | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | United States |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | United States |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | 63112 | United States |
| Washington U CRS | St Louis | Missouri | United States |
| Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha | Nebraska | 681985130 | United States |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | 10003 | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | United States |
| Beth Israel Med. Ctr., ACTU | New York | New York | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | United States |
| Unc Aids Crs | Chapel Hill | North Carolina | 275997215 | United States |
| Carolinas HealthCare System, Carolinas Med. Ctr. | Charlotte | North Carolina | 28203 | United States |
| Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro | North Carolina | 27401 | United States |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 452670405 | United States |
| Case CRS | Cleveland | Ohio | 44106 | United States |
| MetroHealth CRS | Cleveland | Ohio | 441091998 | United States |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 432101228 | United States |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019469 | Indinavir |
| C109078 | lamivudine, zidovudine drug combination |
| D006918 | Hydroxyurea |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| D015215 | Zidovudine |
| D016049 | Didanosine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012263 | Ribonucleosides |
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