Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
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Purpose
The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Capravirine Drug: Nelfinavir mesylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase II, Single-Blind, Randomized, Placebo-Controlled Study of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen |
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2000 |
[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this trial if they:
- Are HIV-positive.
- Have a CD4 cell count more than 50/mm3.
- Are at least 18 years old.
- Have adequate blood, kidney, and liver functions.
- Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination.
Exclusion Criteria
Patients will not be eligible for this trial if they:
- Have had any protease inhibitor or capravirine treatment.
- Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry.
- Have had radiation therapy within 28 days of study entry.
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Pacific Oaks Med Group | |
| Beverly Hills, California, United States, 90211 | |
| First Choice Medical | |
| Palm Springs, California, United States, 92262 | |
| Apogee Med Group | |
| San Diego, California, United States, 92101 | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| Saint Francis Mem Hosp / HIV Care Unit | |
| San Francisco, California, United States, 94109 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Bach and Godofsky | |
| Bradenton, Florida, United States, 34205 | |
| Clin Research of West Florida | |
| Clearwater, Florida, United States, 33765 | |
| Community Health Care | |
| Fort Lauderdale, Florida, United States, 33306 | |
| Therafirst Med Ctr | |
| Fort Lauderdale, Florida, United States, 33308 | |
| South Shore Hosp | |
| Miami, Florida, United States, 33139 | |
| Immunity Care and Research Inc | |
| Miami Beach, Florida, United States, 33139 | |
| Orange County Health Dept | |
| Orlando, Florida, United States, 32805 | |
| Infectious Diseases Associates | |
| Sarasota, Florida, United States, 34239 | |
| Hillsborough County Health Dept | |
| Tampa, Florida, United States, 33602 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| Polk County Health Dept | |
| Winter Haven, Florida, United States, 33881 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Braude Mermin Spivey MD PC | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Massachusetts | |
| Fenway Community Health Ctr | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts Gen Hosp | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New Jersey | |
| VAMC New Jersey Healthcare System | |
| East Orange, New Jersey, United States, 07018 | |
| Jersey Shore Med Ctr | |
| Neptune, New Jersey, United States, 07753 | |
| Infectious Disease Assoc of Central Jersey | |
| Somerville, New Jersey, United States, 08876 | |
| United States, New York | |
| Biomedical Research Alliance of New York | |
| Jamaica, New York, United States, 11432 | |
| North Shore Univ Hosp | |
| Manhasset, New York, United States, 11030 | |
| Liberty Medical | |
| New York, New York, United States, 10014 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| Central Texas Clinical Research | |
| Austin, Texas, United States, 78705 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77555 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| Puerto Rico | |
| Clinical Research Puerto Rico Inc | |
| San Juan, Puerto Rico, 009091711 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004985 History of Changes |
| Other Study ID Numbers: | 286D, AG1549-509 |
| Study First Received: | March 15, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors RNA, Viral |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Protease Inhibitors |
Nelfinavir Reverse Transcriptase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013