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Zalcitabine Clinical Trials

A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy
To evaluate and compare the effectiveness and toxicity associated with didanosine ( ddI ) and zalcitabine ( dideoxycytidine; ddC ) in patients with HIV infection who are intolerant of or have failed zidovudine ( AZT ) therapy. Alternative and [more...]  less toxic treatments need to be investigated for the treatment of HIV infection. Studies have shown that the dideoxynucleosides ddI and ddC may be effective antiretroviral agents in the treatment of HIV-infected individuals. However, ddI and ddC have yet to be compared on the basis of patient survival, drug tolerance, immunologic and virologic effectiveness, and the incidence of opportunistic infection or opportunistic malignancy. Results of this study will yield information regarding the relative therapeutic benefits and toxicities of each drug while providing alternative treatment to patients who are unable to tolerate or have had progression of disease while on AZT.
Status: Completed Start Date:  Completion Date: September 1992
A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)
To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or advanced AIDS-related complex (ARC). Treatments using [more...]  AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.
Status: Completed Start Date:  Completion Date: 
Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.
To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have already received at least 1 year of AZT therapy and to [more...]  define the safety profile. ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT.
Status: Completed Start Date:  Completion Date: 
(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) Versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a different safety profile than AZT. In clinical studies, [more...]  ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted.
Status: Completed Start Date:  Completion Date: 
A Study of ddC in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Have Not Had Success With Zidovudine (AZT)
AMENDED: To provide ddC for patients with AIDS or advanced ARC who have failed treatment with, are intolerant to or are ineligible to receive zidovudine (AZT) and to demonstrate that ddC monotherapy is safe, and tolerable in this patient population. [more...]  Original design: To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or advanced AIDS-related complex (ARC) who have failed treatment with or are intolerant to zidovudine (AZT) and who are also intolerant to dideoxyinosine (ddI); to demonstrate that ddC monotherapy is safe and tolerable in the treatment of patients who previously experienced either treatment failure, hematologic intolerance or myositis with AZT treatment and pancreatitis or other toxicities (except peripheral neuropathy with ddI).
Status: Completed Start Date:  Completion Date: 
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease. The rapid emergence of [more...]  resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
Status: Completed Start Date:  Completion Date: September 1996
A Study of Dideoxycytidine in HIV-Infected Patients
To determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine; ddC ) is given orally and how long the drug stays in the body after absorption or intravenous (IV) administration. Laboratory tests have [more...]  shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Status: Completed Start Date:  Completion Date: December 1988
The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety [more...]  and the tolerance of the coadministration of zidovudine and ddI or ddC.
Status: Completed Start Date:  Completion Date: 
An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT), or who have completed other ddC protocols, or who are ineligible for ongoing clinical [more...]  trials.
Status: Completed Start Date:  Completion Date: 
A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
To determine the long-term safety and tolerance of four alternating and two intermittent regimens of zidovudine ( AZT ) and 2',3'-dideoxycytidine ( zalcitabine; ddC ) in the treatment of patients with advanced HIV disease who have had to discontinue AZT because of [more...]  true hematologic intolerance to standard reduced doses of AZT. AIDS is a serious infectious disease caused by a new family of retrovirus which is spread primarily through sexual contact and administration of blood or blood products. Individuals who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS virus agent. AZT and ddC have both been tested as antiviral agents and their potentially beneficial effects may be limited by time- and dose-dependent toxicity. A combination regimen using shorter courses of AZT and ddC might therefore be able to sustain treatment without producing toxicity. In addition, since the two drugs exhibit their major toxicity on different organ systems, cumulative or additive toxicity would not be expected.
Status: Completed Start Date:  Completion Date: February 1995
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment. Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by [more...]  giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.
Status: Completed Start Date:  Completion Date: April 2002
A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients
Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of AIDS-related conditions in HIV-infected patients. Secondary: To [more...]  compare the frequency and severity of adverse experiences in the three regimens. To compare the mortality rates in the three regimens. To compare the effects of antiretroviral regimens on CD4+ cell levels. Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.
Status: Completed Start Date:  Completion Date: December 1995
A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
Status: Completed Start Date:  Completion Date: November 1995
A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons [more...]  who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3. Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
Status: Completed Start Date:  Completion Date: May 1993
A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and [more...]  laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria. In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
Status: Completed Start Date:  Completion Date: April 1995
A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine
To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).
Status: Completed Start Date:  Completion Date: 
A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment
To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different [more...]  regimens.
Status: Completed Start Date:  Completion Date: 
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced [more...]  HIV infections treated with nucleoside analog therapy. IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
Status: Completed Start Date:  Completion Date: September 1996
The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT. PER 02/27/95 AMENDMENT: To evaluate the [more...]  efficacy and safety of both blinded and open-label combination therapy.
Status: Completed Start Date:  Completion Date: 
Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC. SECONDARY: To investigate the pharmacokinetics and effects on [more...]  various clinical parameters of the three regimens.
Status: Completed Start Date:  Completion Date: 
A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma
To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC). AIDS [more...]  patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
Status: Completed Start Date:  Completion Date: September 1996
A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3
To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with HIV infection and CD4 count < 400 cells/mm3. [more...]  AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.
Status: Completed Start Date:  Completion Date: February 1995
Dideoxycytidine ( Ro 24-2027 ). A Treatment Protocol for the Use of Dideoxycytidine ( ddC ) in Patients With AIDS or Advanced ARC Who Cannot Be Maintained on Zidovudine ( AZT ) Therapy.
To provide zalcitabine ( ddC ) for patients with AIDS or Advanced ARC in whom zidovudine ( AZT ) is contraindicated, or who have failed treatment with or are intolerant to AZT and to demonstrate that ddC monotherapy is safe, and tolerable in this [more...]  patient population.
Status: Completed Start Date:  Completion Date: 
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Status: Completed Start Date:  Completion Date: 
An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492
To demonstrate that zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable in the treatment of patients with AIDS or advanced AIDS related complex (ARC) who previously demonstrated intolerance to zidovudine (AZT) treatment while in Protocol N3300 (NIAID ACTG 114) [more...]  or N3492 (NIAID ACTG 119). NOTE OF CAUTION FOR CONCOMITANT MEDICATIONS ON STUDY: Patients on amphotericin, pyrimethamine, sulfadiazine, trimethoprim/sulfamethoxazole, ganciclovir, intravenous pentamidine, intravenous acyclovir or oral acyclovir or other bone marrow or renal toxic drugs may not tolerate concomitant ddC. If these drugs are given concomitantly with ddC, patients should have frequent clinical and laboratory assessments, as appropriate. Drugs that are nephrotoxic or have the potential to cause peripheral neuropathy might be expected to cause increased toxicity when co-administered with ddC. Drugs that could cause serious additive toxicity when co-administered with study medication will be allowed for treatment of an acute intercurrent illness or opportunistic infection at the discretion of the investigator. Their use may be allowed with interruption of study drug for up to 35 days per episode, for a total of 90 days for the study. If the patient's condition requires chronic administration of these medications, the patient will be discontinued from study medication and followed.
Status: Completed Start Date:  Completion Date: 
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Zalcitabine Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Zalcitabine. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Zalcitabine studies are federally regulated with strict guidelines to protect patients.

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