The purpose of this study is to look at the effectiveness of tenofovir disoproxil fumarate
(TDF) in HIV-infected patients who have never taken anti-HIV drugs.
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a plasma viral load (level of HIV in the blood) of 10,000 copies/ml or more.
- Have a CD4 count of 50 cells/mm3 or more.
- Have a negative pregnancy test.
- Agree to use 2 forms of barrier birth control while on the study and for 30 days
- Are 18 to 65 years old.
Patients will not be eligible for this study if they:
- Have had treatment with any of the following types of anti-HIV drugs: nucleoside
reverse transcriptase inhibitors, nucleotide reverse transcriptase inhibitors (e.g.,
adefovir dipivoxil or TDF), protease inhibitors, or nonnucleoside reverse
- Have received a vaccination within 30 days before study entry.
- Have had a new AIDS-defining illness diagnosed within 30 days before study entry.
- Are taking any of the following: drugs that may cause kidney problems, including
aminoglycoside antibiotics, cidofovir, cisplatin, foscarnet, intravenous (IV)
amphotericin B, IV vancomycin, oral and IV ganciclovir, and valganciclovir;
probenecid; chemotherapy; steroid drugs; interleukin-2; or investigational drugs.
- Are pregnant or breast-feeding.
- Have difficulty taking, absorbing, or tolerating drugs by mouth, as may be shown by
long-term nausea or vomiting.
- Abuse alcohol or drugs.
- Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
- Have other infections that need injectable antibiotics within 15 days before study
- Have had kidney or bone disease.
- Have any medical conditions or past treatments that the study investigator believes
would make the patient unsuitable for the study.