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The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00007436
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 9-(2-phosphonylmethoxypropyl)adenine

Brief summary

The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.

Detailed description

Patients take tenofovir DF in combination with other antiretrovirals.

Interventions

DRUGTenofovir disoproxil fumarate

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients may be eligible for this study if they: * Have completed another study on tenofovir DF without toxicity. * Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.

Exclusion criteria

Patients will not be eligible for this study if they: * Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir. * Are taking agents that affect kidney function, such as probenecid. * Are receiving systemic chemotherapy. * Are taking systemic corticosteroids. * Are taking experimental drugs except those that are approved by Gilead. * Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies. * Are pregnant or breast-feeding.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026